Derks Vacature Kwaliteit

Quality Services and Solutions Delivery Engineer

Offer
  • a challenging job at a global healthcare company
  • operational role in an international environment
  • supporting the Accelerated Patient Safety and Quality program
  • a temporary contract till the end of June 2022
Position

As a Quality Services and Solutions Delivery Engineer you support the Service and Solutions delivery organisation in delivering compliant MS-QMS through its full lifecycle. You maintain and monitor the defined QMS as applicable to ensure continuous improvement. Also, you execute all QMS operational processes to support the SSD organisation (Document Control, Training Management, Change Request, Quality Plan). Furthermore, you develop knowledge in in the area of QMS management. You understand the PQMS strategy and the organisational excellence process framework. You also continuously develop quality and regulatory expertise and work as a qualified expert in quality and regulatory areas aiming to support the maintenance and monitoring of the QMS. Last but not least, you receive instructions on day to-day work, general instructions on new assignments and you interact frequently with your peer group and supervisor. You participate in the Daily Management Team.

Profile
  • bachelor’s degree or equivalent, ideally in a related field
  • typically requires 2 to 4 years of related regulatory and quality experience in a highly-regulated environment
Organisation

Our relation is internationally active in the healthcare industry. They sell their products to the international market. They are always looking for new innovative medical device products by investing in research and development. With these investments they hope to stay on top of the market. They design the product through the eyes of the end user, combined with an appealing design. The organisation is always looking for improvement of their processes. Therefore, they would like to get in touch with a Quality Services and Solutions Delivery Engineer.

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/21-157-DD, to Sandra van Putten: info@derksenderks.nl.

For further information, please call Sandra van Putten at number +31 (0)33 472 80 87.

Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Derks vacature overig

(Startende) Productie Apotheker

Aanbod
  • ideale kennismaking met de farmaceutische industrie;
  • concreet bijdragen aan verschillende farmaceutische processen;
  • werken in een prettige, proactieve en collegiale werkomgeving;
  • meegroeien met een ambitieuze organisatie;
  • marktconform salaris.
Functie

Als Productieapotheker sta je midden in de dynamiek en hectiek van de productieprocessen. In deze functie zorg je ervoor dat alle productieprocessen voldoen aan de hoge interne en externe kwaliteitsnormen. Concreet komen je taken neer op het handhaven van de voorschriften voor onder andere productieprocessen, producten en omgeving en het plannen van eventuele correctieve en preventieve acties. Je anticipeert op veranderingen in de regelgeving en je gaat proactief op zoek naar oplossingen. Je stelt bereidingsprotocollen op en zorgt ervoor dat deze bereidingen op de juiste manier worden uitgevoerd. Je bent verantwoordelijk voor het gehele proces, ook voor het vrijgeven van deze bereidingen.

Onze relatie heeft zichzelf hoge doelen gesteld ten aanzien van efficiency, kwaliteit en productiviteit, waardoor van jou een initiërende en motiverende rol wordt verwacht in projectgroepen. Bij de implementatie en optimalisatie van nieuwe processen krijg je ook een sleutelrol. Uiteraard draag je bij aan in- en externe audits en train je de collega’s van productie, engineering en maintenance in GMP en andere farmaceutische vakkennis. Kortom, een veelzijdige baan, waarin je talenten op het gebied van farmacie, kwaliteitszorg en samenwerking nu en in de toekomst ten volle aangesproken worden!

Profiel
  • afgeronde MSc-opleiding farmacie;
  • maximaal drie jaar werkervaring;
  • sterke communicatieve vaardigheden en uitstekend kunnen samenwerken;
  • hebben van een ‘can-do mentaliteit’;
  • pragmatisch, flexibel, out-of-the-box denken, probleemoplosser, zelfstarter, aanpakker;
  • ambitieus, leergierig, openstaan voor nieuwe ervaringen.
Bedrijf

Onze opdrachtgever levert als onafhankelijke en groeiende onderneming farmaceutisch maatwerk voor specifieke patiëntbehoeften, waardoor er zorg wordt gedragen voor een doelmatige geneesmiddelenvoorziening. Zij zetten zich in om geneesmiddelen met een medische noodzaak beschikbaar te maken en beschikbaar te houden. Dit zijn in bepaalde gevallen geneesmiddelen die voor een specifieke patiëntengroep of indicatie onmisbaar zijn. Op locatie ontwikkelt, produceert en registreert onze opdrachtgever haar eigen producten. Ze zetten de producten met eigen merknamen zelfstandig in de markt. De geregistreerde geneesmiddelen worden via de farmaceutische groothandels aan apotheken, ziekenhuisapotheken en apotheekhoudende huisartsen in Nederland geleverd. De organisatie heeft de afgelopen jaren een sterke groei doorgemaakt. Om verder vorm te geven aan deze groei zijn we op zoek naar een pragmatische Productie Apotheker.

Reactie

Geïnteresseerd? Stuur je curriculum vitae en motivatie, onder vermelding van referentienummer WL/21-047-DD, naar Minke Gastreich, info@derksenderks.nl.

Voor meer informatie kun je bellen met Minke Gastreich via 033 – 4728087.

Een assessment kan deel uitmaken van de selectiemethode.

Onze opdrachtgever heeft er bewust voor gekozen om de procedure door Derks & Derks B.V. te laten behandelen. Wij vragen nadrukkelijk je reactie aan Derks & Derks te richten.

Is dit niet helemaal de functie die je zoekt? Kijk dan op http://www.derksenderks.nl/nl/nieuwe-baan/vacatures voor andere interessante vacatures!

Derks Vacature Kwaliteit

QA specialist – GDP/GMP

Offer
  • a challenging job within a large pharmaceutical company
  • a temporary assignment till 1st of July 2022.
  • contract of Derks & Derks Secondment & Interim
Position

As a Qualified Person-Logistics, reporting to the Associate Director D&L Quality EMEA, you will ensure that all products are handled and transported in accordance with all applicable regulatory requirements to meet both internal and external customer demands, the Product License, GDPs and contractual obligations.

As a Qualified Person-Logistics you will ensure the quality performance of the regional/global D&L transportation partners through direct quality oversight, support, and technical advice. This includes overseeing activities such as partner selection and GDP due diligence, establishing quality agreements and ensuring permanent audit readiness. You will work in close cooperation with the Quality and Supply Chain network to ensure quality performance of the D&L transportation partners across the globe. You will provide support to build effective quality systems support continuous improvement activities. This position can be based in Haarlem or Oss (The Netherlands), Heist-op-den-Berg (Belgium) or Hungary, Czech Republic and requires travelling (10-20% of the time) in the EMEA-region.

Profile
  • bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Logistics, Supply Chain Management, or Engineering
  • at least 4 years of experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP/GDP and regulatory requirements
  • excellent problem solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments; must be able to apply risk management principles
  • ability to influence management of complex operations, protect company image and reputation with patients, medical stakeholders and regulatory agencies
  • strong demonstrated interpersonal, communication, negotiation, persuasive and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations, able to handle organizational complexity and ambiguity
  • exemplary people/team collaboration experience, including speaking candidly, and motivating teams
  • excellent oral and written communication skills in English.
Organisation

Our client is a world leader in the healthcare industry. Through their medicines, vaccines, biological therapies, and support services, they offer health solutions for people and animals in more than 140 countries. They also demonstrate their commitment to an increasing access to healthcare through far-reaching programs that donate and deliver their products to people in need. The organisation has three main locations with approximately 4,500 employees.

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/21-080-DD, to Renato Marques: info@derksenderks.nl.

For further information, please call Renato Marques at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

If this is not quite the position you are seeking, please check http://www.derksenderks.nl/vacatures for other interesting jobs!

Qualified Person (QP)

Aanbod
  • uitdagende baan binnen een grote farmaceutische organisatie in Nederland;
  • werken binnen een internationale omgeving;
  • uitstekende secundaire arbeidsvoorwaarden.
Functie

Als Qualified Person (QP) zorg je dat de producten voor klinisch onderzoek zijn gecertificeerd voor de distributie naar de locaties voor klinisch onderzoek conform de GMP Annex 13 en 16. Je certificeert ook de Supply Chains voor Clinical Manufacturing & Testing. Hierbij begeleid je ook interne en/of externe audits indien nodig. Je reviewt de batch documentatie en je levert input op de kwaliteitsstrategie door te adviseren op het gebied van compliance en kwaliteit gerelateerde verbeteringen en het initiëren en het ontwikkelen van farmaceutisch beleid en procedures. Je bent een ambassadeur van het kwaliteitsbewustzijn en rapporteert kritische afwijkingen. Ook zorg je ervoor dat elke batch is geproduceerd en gecontroleerd in overeenstemming met de wetten en met de vereisten van de handelsvergunningen. Ook ben je verantwoordelijk voor het uitvoeren van batchcertificering en de daaropvolgende registratie van de gecertificeerde batch in het vrijgaveregister. Je communiceert met collega’s wereldwijd en met externe partijen. Uiteraard ondersteun je de afdeling bij Continuous Improvement activiteiten en projecten. Ook het opbouwen van relaties en het frequent onderhouden van contacten met diverse collega’s, zowel binnen de locatie Heerenveen als met collega’s van andere vestigingen, vallen onder jouw taken.

Profiel
  • afgeronde wo-opleiding Biotechnologie, (Micro-)Biologie, Farmacie met apothekersdiploma (of equivalent);
  • meerdere jaren werkervaring als QP in de farmaceutische industrie;
  • ervaring met het implementeren van kwaliteitsverbeteringen;
  • sterke persoonlijkheid die in staat is zelfstandig besluiten te nemen;
  • proactief, besluitvaardig, kritisch en stressbestendig;
  • uitstekende communicatieve vaardigheden (in woord en schrift) in het Nederlands en Engels.
Bedrijf

Sharp Packaging Services werkt over de hele wereld aan het creëren van unieke commerciële en klinische verpakkingsoplossingen voor de farmaceutische en biotechnologische industrie. Het bedrijf, in totaal zo’n 1.800 professionals, bestaat uit twee dynamische internationale divisies: Sharp Packaging Solutions en Sharp Clinical Services. Met state-of-the-art faciliteiten in de Verenigde Staten, het Verenigd Koninkrijk, België en Nederland is Sharp een sterke en gerespecteerde servicepartner. Sharp heeft een uitzonderlijke wereldwijde reputatie opgebouwd voor het ontwerp, de serialisatie en de productie van innovatieve, kosteneffectieve conformiteitsverpakkingen voor zelfs de meest complexe producten. Hun uitgebreide assortiment omvat blisterverpakkingen, flessen, zakjes en stickpacks. Hun expertise gaat veel verder en stelt hen in staat de industrie te ondersteunen in elke fase van ontwerp, ontwikkeling, productie en levering. De afdeling klinische diensten is een van ’s werelds toonaangevende leveranciers van innovatieve klinische supply chain services, met een getalenteerd en zeer ervaren team dat elk aspect van de supply chain kent. De diensten omvatten alles, van de ontwikkeling en productie van geneesmiddelen tot het verpakken van klinische benodigdheden, etikettering, distributie, auditing van gekwalificeerde personen en sourcing van vergelijkers. De Nederlandse campus bestaat uit twee locaties die worden beheerd door een ervaren team met één gemeenschappelijk kwaliteitsmanagementsysteem. Om het kwaliteitsteam te versterken, met nadruk op het gebied van geneesmiddelen voor onderzoek, zijn zee op zoek naar een gedreven, samenwerkingsgerichte Qualified Person.

Reactie

Geïnteresseerd? Stuur je curriculum vitae en motivatie, onder vermelding van referentienummer WS/21-086-DD, naar Djamila Hagemans, info@derksenderks.nl.

Voor meer informatie kun je bellen met Djamila Hagemans via 033 – 4728087.

Een assessment kan deel uitmaken van de selectiemethode.

Onze opdrachtgever heeft er bewust voor gekozen om de procedure door Derks & Derks B.V. te laten behandelen. Wij vragen nadrukkelijk je reactie aan Derks & Derks te richten.

Is dit niet helemaal de functie die je zoekt? Kijk dan op http://www.derksenderks.nl/nl/nieuwe-baan/vacatures voor andere interessante vacatures!

Derks vacature inkoop-logistiek

Supply Chain Specialist (Fulltime)

Offer
  • a challenging job within a large pharmaceutical company
  • a temporary assignment till 31 March 2022, with huge chance of extension
  • contract of Derks & Derks Secondment & Interim
Position

As a Supply Chain Specialist, reporting to the Distribution and Logistics Lead MER, you will be responsible for supporting the department by being part of a project group that investigates the effect on costs for a number of different setups in the logistics network. Your role within this group will be to retrieve the source data and perform the calculations. You may be required to help out in the demand planning process (no knowledge required; training will be provided). You will also create tools in Microsoft that can support the department and reduce the workload. The concept of the tool will be communicated to you, the development and roll out of the tool will be your responsibility. This is a very challenging, demanding, and analytical position inside the supply chain department of an important pharmaceutical company.

Profile
  • at least 5 years of relevant work experience with a demonstrated record
  • experience in SAP for data consolidation and generation of reports
  • very experienced in Microsoft tools like Power BI, Excel
  • strong analytical skills, understanding of numbers
  • proficiency in English, Dutch is a plus
  • experience with working in an international background
  • ability to work independently without direct supervision
  • willingness and ability to work flexible hours (37,5 hours per week)
Organisation

Our client is a world leader in the healthcare industry. Through their medicines, vaccines, biological therapies, and support services, they offer health solutions for people and animals in more than 140 countries. They also demonstrate their commitment to an increasing access to healthcare through far-reaching programs that donate and deliver their products to the people who need them. The organisation has three main locations with approximately 4,500 employees. This position is located in Haarlem.

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/21-156-DD, to Renato Marques: info@derksenderks.nl.

For further information, please call Renato Marques at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

If this is not quite the position you are seeking, please check http://www.derksenderks.nl/vacatures for other interesting jobs!

Derks vacature kwaliteit

Junior Quality Specialist

Offer
  • a permanent position within Quality Systems
  • a challenging role in a growing pharmaceutical company
  • building/changing a QMS
  • working in an international environment
Position

As Junior Quality Specialist you will improve and maintain part of the Quality Management System to ensure that the quality system at our client is compliant with EU and USA GMP legislation, guidelines and/or our clients quality expectations. You will assist, advise and train colleagues regarding GMP compliance and play a substantial role in QA-related projects. Besides this, you will write, implement, review, and maintain SOPs, policies, and other QA related documentation in alignment with applicable GxP guidelines relevant for a QMS. You will identify documents which need to be created or updated and ensure this is organized. You will also perform and review internal and external audits, as co-auditor, to determine compliance with applicable guidelines (like GMP, GLP, ISO, GDP, GCP, GVP). After some training and experience you will act as a lead auditor. As Quality Systems Specialist you will represent QA Systems in significant complex projects and identify compliance risks and ensure these are addressed adequately. Also, you will communicate and negotiate with contractors and suppliers, with respect to deviations, configuration, validation, implementation, and complex projects. Furthermore, you will proactively propose ideas for improvements; and provide subject matter expert reports as required.

Profile
  • bachelor’s or university degree in biopharmaceutical sciences, (bio)chemistry, engineering, or equivalent
  • experience in (bio)pharmaceutical environment
  • good knowledge of GMP regulations for EU and US (GMP, GLP and GDP)
  • preferably knowledge of and experience with ERP (e.g., SAP) and e-DMS (e.g. Master Control) systems
  • preferably knowledge of and experience with project management
  • required competences: initiative, persuasiveness, problem analysis, oral and written communication, decisiveness
Organisation

Our client develops innovative protein therapeutics for the treatment of genetic disorders. The company is ready for further scientific, technological and product development, and additional commercial rollouts. They have specialized themselves in the production of protein therapeutics. Their innovative technology and processes are aimed at purification and formulation of these products. They have their headquarters in Leiden, the Netherlands and is growing quickly. At this moment they are open to meet an experienced candidate for the position of Senior QA Specialist.

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WS/21-032-DD, to Djamila Hagemans: info@derksenderks.nl.

For further information, please call Djamila Hagemans at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Derks vacature medische experts

Medical Science Liaison (MSL)

Aanbod
  • dynamische positie binnen een internationale omgeving;
  • werken in een vooruitstrevende en mensgerichte organisatie met een collegiale sfeer;
  • werken bij een professionele en internationale organisatie;
  • goede arbeidsvoorwaarden.
Functie

Als Medical Science Liaison draag je zorg voor de wetenschappelijke backbone van het bedrijf (intern en extern) en geef je advies over de producten van de organisatie. Je initieert en onderhoudt relaties met de belangrijkste Healthcare professionals en onderzoekers (Key Opinion Leaders) van belangrijke academische centra, ziekenhuizen en onderzoeksinstellingen. Je beheert zelfstandig jouw rayon, welke zich op nationaal niveau bevindt. Daarnaast heb je een gebied overschrijdende en verbindende rol tussen de zorgverleners en de industrie. Voor het overbrengen van inhoudelijke kennis organiseer je regionale en landelijke opleidingsevenementen en workshops. Daarnaast houd je je bezig met (pre-/re-) launch activiteiten en het bijwonen van (inter)nationale congressen. De belangrijkste resultaatgebieden zijn dan ook medische kennis, tactisch handelen en medisch ethisch handelen. Je bent communicatief sterk, hebt overtuigingskracht en voert op wetenschappelijk niveau conversaties met verschillende artsen. Daarnaast ben je op de hoogte van relevante klinische ontwikkelingen en vertaal je deze informatie, om dit vervolgens op de juiste manier over te brengen. Je rapporteert in deze functie aan de Medical Manager in Duitsland en werkt nauw samen met de Medical Advisor voor Nederland. Het bedrijf omarmt het concept van waarde gedreven zorg (Value-Based Healthcare) en heeft hierin dan ook verschillende projecten lopen waarbij je als MSL aansluit.

Profiel
  • afgeronde (bio)medische wo-opleiding;
  • ervaring binnen de farmaceutische industrie;
  • ervaring als MSL, of na commerciële ervaring op zoek naar inhoudelijke verdieping, of na promotietraject overstap naar commerciële kant;
  • op wetenschappelijk niveau de conversatie aan kunnen gaan met verschillende artsen;
  • in staat om kennis (intern en extern) over te brengen;
  • uitstekende beheersing van de Nederlandse en Engelse taal in woord en geschrift; beheersing van de Duitse taal is een pre;
  • uitstekende communicatieve vaardigheden, samenwerken, proactief, leergierig, open-minded, extravert.
Bedrijf

Onze opdrachtgever is wereldwijd actief, gevestigd in 55 landen en telt circa 5.000 medewerkers. Ze zijn al vele jaren gerenommeerd om hun activiteiten in ontwikkeling, productie, registratie en verkoop van geneesmiddelen voor de indicatiegebieden gynaecologie, endocrinologie, gastro-enterologie en urologie. In Nederland nemen ze een bijzondere positie in. Ze zijn hier 30 jaar actief en gekend als professioneel en sterk mensgericht. “People come first”: mensen zijn voor hen belangrijker dan kwartaalcijfers. Deze visie vertaalt zich in ondernemende collega’s, waarin iedereen op elk niveau eigen verantwoordelijkheden heeft en neemt. Zoals in elke onderneming zijn innovaties, cijfers en resultaten essentieel. Maar de oorsprong, waarin mensen vooraan staan, blijft het leidende principe.

Reactie

Geïnteresseerd? Stuur je curriculum vitae en motivatie, onder vermelding van referentienummer WS/21-087-DD, naar Djamila Hagemans, info@derksenderks.nl.

Voor meer informatie kun je bellen met Djamila Hagemans via 033 – 4728087.

Een assessment kan deel uitmaken van de selectiemethode.

Onze opdrachtgever heeft er bewust voor gekozen om de procedure door Derks & Derks B.V. te laten behandelen. Wij vragen nadrukkelijk je reactie aan Derks & Derks te richten.

Is dit niet helemaal de functie die je zoekt? Kijk dan op http://www.derksenderks.nl/nl/nieuwe-baan/vacatures voor andere interessante vacatures!

Derks Vacature Kwaliteit

Training Manager

Offer
  • a challenging job at a global Healthcare company
  • an operational role in an international environment
  • a temporary contract until October 2022
Position

In this role, you have the opportunity to work closely together with the Quality Management Systems (QMS), Market Central Teams, the Market Quality & Regulatory (Q&R) Leaders, the Function Leaders and Global Quality Compliance Learning team. As a Training Manager you will execute the project plan defined by the company to move to new ways of working (role- based education model): “ensure we can assign the right training, to the right person, at the right time”. You will work both on training management (70%) and QMS activities (30%). As it refers to training management, you will ensure that their training processes and activities are fit-for-purpose and compliant with the medical device regulations, ensuring that they assign the right training to the right person, measuring and reporting on the efficiency of the existing training practices and processes; and acting upon. Your tasks regarding QMS may include the support to the deployment of new processes as well as the update of existing procedures.

Profile
  • bachelor level with at least 5 years of experience in a highly regulated company (Medical Devices, Pharma, Automotive, Food, Defence, Aerospace), working with ISO quality standards or GxP requirements
  • experienced with Training Management and administration processes and practices, and with Training Management tools in the quality field and aptitude for other software tools (Word, Excel, Powerpoint and Microsoft SharePoint)
  • experienced with leading and managing medium to large scales projects end-to-end, preferably in the field of training and/or quality
  • excellent organisation skills and able to operate efficiently and effectively in a matrix organisation with a minimum of supervision
  • professional written and oral communication skills across all levels of the organisation
  • accurate, superior planning, problem-solving and trouble-shooting skills (e.g. CAPA, root cause analysis) with attention to detail and follow-through.
  • quality driven, strong customer service focus, with the ability to influence others, at all levels, to achieve goals
  • proficient in English
Organisation

Our relation is international active in the Healthcare industry. They sell their products to the international market. They are always looking for new innovative medical device products by investing in research and development. With these investments they hope to stay on top of the market. They design their products through the eyes of the end user, combined with an appealing design. The organisation is always looking for improvement of their processes. Therefore, they would like to get in touch with a Training Manager.

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/21-154-DD, to Renato Marques: info@derksenderks.nl.

For further information, please call Renato Marques at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Derks Vacature Biotech

Senior Quality Specialist

Offer
  • a permanent position within Quality Systems
  • a challenging role in a growing pharmaceutical company
  • building/changing a QMS
  • working in an international environment
Position

As Senior Quality Specialist you will improve and maintain part of the Quality Management System to ensure that the quality system at our client is compliant with EU and USA GMP legislation, guidelines and/or our clients quality expectations. You will assist, advise and train colleagues regarding GMP compliance and play a substantial role in QA-related projects. Besides this, you will write, implement, review, and maintain SOPs, policies, and other QA related documentation in alignment with applicable GxP guidelines relevant for a QMS. You will identify documents which need to be created or updated and ensure this is organized. You will also perform and review internal and external audits, as co-auditor, to determine compliance with applicable guidelines (like GMP, GLP, ISO, GDP, GCP, GVP). After some training and experience you will act as a lead auditor. As Quality Systems Specialist you will represent QA Systems in significant complex projects and identify compliance risks and ensure these are addressed adequately. Also, you will communicate and negotiate with contractors and suppliers, with respect to deviations, configuration, validation, implementation, and complex projects. Furthermore, you will proactively propose ideas for improvements; and provide subject matter expert reports as required.

Profile
  • bachelor’s or university degree in biopharmaceutical sciences, (bio)chemistry, engineering, or equivalent
  • experience in (bio)pharmaceutical environment
  • good knowledge of GMP regulations for EU and US (GMP, GLP and GDP)
  • extensive knowledge of GMP regulations for EU and US (GMP, GLP and GDP)
  • preferably knowledge of and experience with ERP (e.g., SAP) and e-DMS (e.g. Master Control) systems
  • preferably knowledge of and experience with project management
  • required competences: initiative, persuasiveness, problem analysis, oral and written communication, decisiveness
Organisation

Our client develops innovative protein therapeutics for the treatment of genetic disorders. The company is ready for further scientific, technological and product development, and additional commercial rollouts. They have specialized themselves in the production of protein therapeutics. Their innovative technology and processes are aimed at purification and formulation of these products. They have their headquarters in Leiden, the Netherlands and is growing quickly. At this moment they are open to meet an experienced candidate for the position of Senior QA Specialist.

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WS/21-032-NIEUW-DD, to Djamila Hagemans: info@derksenderks.nl.

For further information, please call Djamila Hagemans at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Derks Vacature Kwaliteit

CAPA Engineer (Fulltime)

Offer
  • a challenging job at a global healthcare company
  • an operational role in an international environment
  • a temporary contract till August 2022
Position

As a CAPA Engineer, you will have the opportunity to guide and support business groups, markets and enabling functions to always do the right thing. In this position you will be responsible for facilitating product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring, as well as performing periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement. You will also be required to train and mentor CAPA owners in all required elements and best practices of CAPA, including containment, root cause analysis, correction, corrective and preventive actions and effectiveness checks.

Profile
  • bachelor’s degree in an engineering or scientific-related field or equivalent; technical experience
  • 5+ years’ work experience in quality functions, experience with CAPA is required
  • experience in medical/automotive related industry is preferred
  • able to understand and analyse complex problems, including software and hardware design issues
  • demonstrated intensive knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations
  • applicable knowledge of appropriate global regulations, requirements, and standards such as 21CFR Parts 803, 806, and 820, ISO 13485, ISO 9001, and ISO 14971
  • demonstrated ability to collaborate with the business and effectively interact with and influence employees, and managers on all levels
  • strong project management skills, including the ability to manage all CAPA project activities
Organisation

Our relation is international active in the healthcare industry. They sell their products to the international market. They are always looking for new innovative medical device products by investing in research and development. With these investments they hope to stay on top of the market. They design the product through the eyes of the end user, combined with an appealing design. The organisation is always looking for improvement of their processes. Therefore, they would like to get in touch with a CAPA Engineer.

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/21-153-DD, to Renato Marques: info@derksenderks.nl.

For further information, please call Renato Marques at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.