Derks vacature kwaliteit

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
  • minimum of four years of experience in (bio)pharmaceutical environment, with at least four years in Quality Assurance
  • 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-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.

Interimmanager Healthcare

Uitdagende veranderopdrachten binnen Healthcare die vragen om een ervaren interimmanager met een persoonlijke benadering, een toekomstgerichte visie en een bedrijfsmatige blik.

Aanbod

  • posities op management- en directieniveau binnen Healthcare;
  • opdrachtgevers als ziekenhuizen, zorginstellingen en ZBC’s;
  • verantwoordelijkheid voor de aansturing van een team of afdeling;
  • afwisselende functies met vaak een directe invloed op strategisch niveau;
  • interim ervaring binnen zorgorganisaties is vereist;

Bedrijf

Wij zijn continu op zoek naar ervaren interimmanagers die een expertise hebben opgebouwd in veranderopdrachten binnen Healthcare. Onze opdrachtgevers zijn ziekenhuizen, ZBC’s en overige zorginstellingen waarmee wij samenwerken. Deze interim vacatures komen enerzijds beschikbaar vanwege het binnen korte termijn vacant komen van een management- of directiepositie, anderzijds doordat er binnen de organisatie een veranderopdracht geformuleerd wordt. Om snel aan de vragen van onze opdrachtgevers te kunnen beantwoorden komen wij graag in contact met ervaren interimmanagers die beschikken over een persoonlijke benadering, een toekomstgerichte visie en een bedrijfsmatige blik.

Derks & Derks is gespecialiseerd in de bemiddeling en ontwikkeling van professionals die actief zijn binnen de Healthcare sector. Vanuit onze kennis en expertise ondersteunen we opdrachtgevers uit het hele spectrum van de zorg. Door verder te kijken dan alleen de zorginstellingen zelf, maar daar ook ziektekostenverzekeraars, leveranciers en overheidsorganisaties bij te betrekken overzien wij de markt en denken we in ons advies breed met je mee. Actuele thema’s en ontwikkelingen binnen Healthcare komen uitgebreid aan de orde in de Masterclass NieuweZorg die wij jaarlijks organiseren voor op innovatie gerichte en gedreven professionals actief op management- en directieniveau in de zorg.

Functie

Als Interimmanager heb je een verantwoordelijke en afwisselende functie. De zwaarte van de managementrol en scope van de aansturing zijn afhankelijk van de organisatie (ziekenhuis dan wel instelling) en het managementniveau (operationeel dan wel directie). Bij aanvang van de opdracht wordt in samenspraak met de opdrachtgever een heldere opdracht omschrijving geformuleerd aan de hand waarvan de uitvoering plaatsvindt. Belangrijk hierbij is of het een veranderopdracht betreft of een tijdelijke vervanging waarvoor een interimmanager wordt ingezet. Per individuele opdracht zullen wij daarover aanvullende informatie verstrekken. Om in aanmerking te komen vragen wij om op deze algemene vacature te solliciteren, zodat wij over uw contactgegevens beschikken, u op de hoogte kunnen houden over relevante opdrachten en vacatures en eventueel alvast uit kunnen nodigen voor een (online) kennismakingsgesprek.

Profiel

  • relevante opleiding op HBO of WO-niveau;
  • aantoonbare relevante interim ervaring;
  • meerdere jaren werkervaring in een management positie;
  • sterke affiniteit met de zorg is een vereiste;
  • uitstekende organisatorische, communicatieve en bedrijfsmatige vaardigheden;
  • stevige persoonlijkheid;
  • innovatief en omgevingsbewust;
  • analytisch sterk, gedreven en overtuigend.

Reactie

Geïnteresseerd? Stuur je curriculum vitae en motivatie, onder vermelding van referentienummer DD/20-053-DD naar Alexander Willemse, info@derksenderks.nl.

Voor meer informatie kun je bellen met Alexander Willemse via 06–12795418.

Voor een specifieke opdracht kan een assessment deel uitmaken van de selectiemethode.

Derks Vacature Techniek

Packaging Engineer

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

As a Packaging Engineer you will be responsible for the development of specifications for new or changed packaging material to ensure trouble-free operation. In this position you will run and manage projects and react to packaging-related operational issues. You will also be required to write documents for packaging-related tests (test protocol, and report) and perform and guide packaging-related tests. As a Packaging Engineer you will look for continuous improvement opportunities and maintain external contacts with existing and possible new vendors, as well as internal contacts with all stakeholders. An important aspect of this role is to anticipate to the problems and develop improvement strategies, as to check if the company can simplify packaging in the future.

Profile
  • bachelor’s degree and or minimum 5 years of experience
  • experience with injectors, chemical science, electronic items, programming
  • good communication skills in both English and Dutch
  • mechanical engineering background in pharma or a related industry (medical devices, baby bottles, etc)
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 in need. The organisation has three main locations with approximately 4,500 employees. This position is located in Boxmeer. The location has approximately 45 employees who are responsible for marketing, sales, distribution, and support of the products.

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/21-106-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 sales-marketing

Product Specialist Ophthalmology

Offer
  • a diverse job at an organisation for surgical products
  • working in an international environment
  • excellent working conditions
  • a lot of personal responsibility, but also flexibility
Position

As a Product Specialist Ophthalmology, you are responsible for achieving and set territory sales objectives and acquire an in-depth knowledge of the products and markets of our client. You will meet customers on a regular and organized basis and promote the range of products. You will convince your client of product benefits and introduce sales promotions and follow-ups. To do so, you need to build a strong and solid relationship with your customers and understand the customer’s situation. Business wise, personally and what makes them “ tick”. You will actively participate in sales activities, courses, training and follow-ups, give presentations and organize scientific meetings with opinion leaders and obtain relevant information for market use. Besides this you need to be aware of the market situation and competitors by obtaining information about competitive moves, introductions and events in the market. Of course, you will be compliant with corporate rules and the local pharmaceutical legislation. You will work in Sout-East of the netherlands eg. Utrecht, Nijmegen, Maastricht, Breda.

Profile
  • a bachelor’s degree or higher, preferably related to medical
  • at least 3 years of experience in a similar role
  • experience within Ophthalmology is a big plus
  • perfect communication skills in both Dutch and English
  • commercial spirit
  • able to operate both independently and in a team
  • analytical and open minded
  • strong negotiator
  • strong and driven personality with perseverance
  • in possession of a driver’s license B
 Organisation

Our client is focused on improving people’s lives with their healthcare products. They are dedicated on their commitment to patients, healthcare providers, other stakeholders and society. Their goal is to build an innovative company committed to advancing global health. A broad range of branded and generic pharmaceuticals, OTC products and medical devices are being manufactured and marketed all around the world. Their Dutch office is located in the Amsterdam region and the culture at their office can best be described as informal, open and accessible. Currently they are looking for a driven Product Specialist Ophthalmology, who wants to have a direct impact on the success of the Vision Care products in the Benelux.

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WS/21-055-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 regulatory-affairs

Regulatory Affairs Labelling Officer

Offer
  • a challenging job within a large pharmaceutical company
  • a temporary assignment till 01-07-2022
  • contract of Derks & Derks Secondment & Interim
Position

As a Regulatory Affairs Labelling Officer, you will be working in Global data management and labeling department which is responsible for the entire regulatory data and document infrastructure electronic publishing of registration dossiers. In this position you will be responsible for  the coordination and implementation of new and revised product labeling, in line with regulatory product files and timelines. You will also be required to maintain close contact with all major stakeholders  regards the labeling and artwork activities. Another important aspect of the function is the collection of all necessary information for the preparation of new product labeling, such as technical specifications, design specifications, registration requirements and texts. You will  also be responsible for proper phasing of the modified materials and control of phasing out of the existing packaging materials.

Profile
  • Bachelor degree is required
  • work experience in Regulatory, QA or Supply Chain Department within the pharmaceutical industry;
  • 3-5 years of relevant experience
  • experience working with an artwork/document management system
  • preferably experience with GMP guidelines within the pharmaceutical industry;
  • fluent English (speaking, reading and writing)
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 Boxmeer. The location has approximately 45 employees who are responsible for marketing, sales, distribution and support of the products.

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/21-104-DD, to Renato Marques: info@derksenderks.nl.

For further information, please call Reanto 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.

Interim Financial Support

Aanbod
  • uitdagende baan binnen een grote farmaceutische organisatie in Nederland;
  • tijdelijk contract van Derks en Derks Detachering;
  • periode van de opdracht duurt tot 31 december 2021.
Functie

In de rol van Interim Financial Support ondersteun je een tweetal managers; de Team Lead Reporting en de Manager Accounting, die wegens drukte een aantal taken bij jou zullen neerleggen. Hierdoor zijn de taken uiteenlopend en kunnen zowel complex als eenvoudig als ad-hoc zijn. De meest voorkomende werkzaamheden hebben betrekking op meerdere facetten van accounting zoals administratie, crediteuren, debiteuren, cash management, grootboekrekening, banken, financial audits, rapportages, belastingen en jaarrekeningen.

Profiel
  • afgeronde mbo-opleiding richting Finance/Accountancy;
  • sterke affiniteit met IT Systemen (ERP) en boekhoudsystemen; uitstekende beheersing van SAP;
  • wil van nature graag “de helpende hand zijn”;
  • minimaal 5 jaar ervaring in soortgelijke functies;
  • ervaring binnen een multinational, bij voorkeur binnen chemische productie;
  • zeer uitgebreide vaardigheid met Excel en data bases;
  • uitstekende communicatieve- en taalvaardigheden in zowel Nederlands als Engels;
  • proactief, resultaatgericht, teamplayer, gedreven, pragmatisch;
  • kennis van IFRS.
Bedrijf

Onze relatie is trots op haar historie met een duidelijke missie en een duidelijk doel. Ze richten zich op de productie van hoogwaardige, effectieve en betaalbare medicijnen die beschikbaar zijn voor een breed publiek. Ze bieden een uitgebreid portfolio aan producten, zowel specialité als generiek, voor een breed spectrum aan diverse acute en chronische indicaties. In Nederland hebben ze twee locaties. De een is meer gericht op het vervaardigen van geneesmiddelen en grondstoffen, en de ander op het verkopen van geneesmiddelen voor therapeutische gebieden. De twee vestigingen werken samen, maar toch ook zelfstandig. Er wordt altijd gezocht naar nieuwe mogelijkheden om verder te groeien of te verbeteren en naar mensen die daaraan willen bijdragen.

Reactie

Geïnteresseerd? Stuur je curriculum vitae en motivatie, onder vermelding van referentienummer DT/21-095-DD, naar Sandra van Putten, info@derksenderks.nl.

Voor meer informatie kan je bellen met Sandra van Putten via 033 – 4728087.

Een assessment kan deel uitmaken van de selectiemethode.

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

Derks Vacature Regulatory Affairs

Document Migration Specialist

Offer
  • a challenging job within a large pharmaceutical company
  • a temporary assignment till 31-05-2022
  • contract of Derks & Derks Secondment & Interim
Position

As a Document Migration Specialist, you will be working in the migration process of a document management system used in the company (within Veeva Vault Platform). In this position you will be responsible to migrate and reclassify documents, both paper and electronic originals (protocols, reports, raw data, literature articles, biologic documents, CMC documents, batch release documents, detailed and critical summaries, sponsor reports, etc.) and upload (scan when necessary) them to the production environment. You will also be required to review and identify documents to determine the appropriate classifications of biologics, clinical, CMC, drug discovery, preclinical, regulatory, statistics, etc, as well as request new study numbers, project codes as necessary, to ensure the accuracy and clearness of the information loaded to the new system.

Profile
  • bachelor’s degree (or equivalent work experience) with 7 years’ experience in a related field and/or industry
  • knowledge of scientific R&D documents within Animal Health or Life Sciences industry is required
  • knowledge and understanding of EPA, FDA GxP, FDA CFR 21 Part 11, OECD GLP, USDA, and VICH regulations and guidelines
  • prior experience with reading and comprehension of biologics, clinical and/or preclinical study related documentation
  • expertise in the understanding of Document Management Systems (preferable Veeva Vault) and/or other repositories
  • expertise in office related software (Microsoft Excel, Microsoft Word, Acrobat, etc.)
  • good communication skills in English, Dutch is a plus
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/21-081-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!