vacature kwaliteit

Quality Lead GMP

Offer
  • core position within an ambitious and growing company
  • part of a highly talented team
  • highly responsible and multi-interface position
  • attractive benefits package
Organisation

Our client is an international, (bio)pharmaceutical company, and active around the entire globe. The site in the northern Netherlands is a multi-product and multi-client site with development and manufacturing facilities for pharmaceutical products for both clinical trials and commercial production. With state-of-the-art development and manufacturing facilities, they serve both midsize and large pharmaceutical companies. More than half or their clients are midsize businesses. Many of these clients are transforming the way pharmaceuticals are developed and commercialized with a new vision for their business model. Our clients service is their means to make that vision into reality. On the other hand capacity, responsiveness and reliable quality are the reasons for large pharmaceutical companies to trust on our clients expertise. In order to maintain consistent management of their clinical and commercial contract manufacturing projects, they are looking for a Quality Lead GMP.

Position

In this role, you are responsible for the final disposition to customers of bulk drug substances and for managing all activities to enable this disposition in an efficient and GMP compliant way according the agreements made with the project manager, the client and according to regulatory expectations.

You propose and implement improvements related to quality and compliance and you advise to project organization and customers on all relevant GMP matters and assure appropriate GMP level of project activities.

You serve as a quality advisor for investigations and recommend actions to ensure continued compliance and avoid recurrence. Furthermore you are responsible for the review and approval of GMP documents associated to the product in compliance with local and corporate SOPs and applicable legislation. Ofcourse you approve investigations assuring that they are complete, accurate, technically justified with the required documented evidence including risk assessment. You evaluate and approve changes associated with the product. You plan, perform and monitor in collaboration with the Project Manager QA activities within the project to ensure results are according the agreement and regulatory expectations. Last but not least you provide assistance and guidance with regard to the Quality Systems to other departments and you propose and implement improvements to these systems. You work in a team with 4 other Quality Leads GMP.

Profile
  • academic level in Life Sciences for instance Biochemistry, Microbiology, Pharmacy, Biotechnology, or Pharmacology
  • minimum of 5 years relevant experience in a (bio)pharmaceutical company
  • experience with project management
  • combination of experience and educational level should be sufficient to act as the person responsible for release of bulk pharmaceutical products
  • strong communicator who adopts a logical approach and is able to interact effectively with project teams and clients
  • strong skills in: planning and organization, decisiveness, problem analysis, able to build support
  • excellent communication and presentation skills in English. Dutch is preferred
Response

Interested? Please send your resume and motivational letter by Email, with reference to WS/19-058-DD to Anneke den Hartog: info@derksenderks.nl.

For further information, please call Anneke den Hartog 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.

vacature kwaliteit

Open sollicitatie: GxP professionals

Aanbod
  • uitdagende posities binnen verschillende life science organisaties;
  • zelfstandige en verantwoordelijke functies van uitvoerend tot strategische niveau;
  • een detacheringcontract of samenwerkingsovereenkomst van Derks en Derks Detachering voor de looptijd van de opdracht.
Bedrijf

Derks & Derks Detachering is opgericht in 2007 en uitgegroeid tot een detacheringsbureau met evidence based personeelsoplossingen voor de farmaceutische, voedingsmiddelen en medische industrie. Onze relaties zijn actief op verschillende werkvelden en bijna allemaal internationaal georiënteerd. De meeste relaties hebben een lange historie binnen Nederland. Onze relaties zijn actief op zoek naar manieren, om de kwaliteit van leven van mens of dier ter verbeteren. Onze relaties zijn met enige regelmaat op zoek naar Kwaliteit, Validatie, Regulatory of Procestechnologie professionals, daarom komen vrij graag in contact met gedreven professionals.

Functie

Als GxP professional ben je inzetbaar in de farmaceutische, voedingsmiddelen of medische industrie. Je hebt werkervaring opgedaan op het gebied van kwaliteit, validatie, regulatory of procestechnologie binnen de genoemde branches. Je bent op de hoogte van alle relevante geldende wet- en regelgeving voor de productie van geneesmiddelen, voedingsmiddelen of medische hulpmiddelen. Je bent actief geweest op uitvoerend of strategische niveau en klaar voor een nieuwe uitdaging.

Profiel
  • minimaal een afgeronde hbo-opleiding;
  • ervaring in een uitvoerende en/of leidinggevend functie;
  • ervaring binnen de farmaceutische en/of voedingsmiddelen en/of medische industrie;
  • ervaring binnen kwaliteit, validatie, regulatory en/of procestechnologie;
  • registratie als QP is een pre;
  • verantwoordelijkheidsgevoel met sterk kwaliteitsbesef;
  • teamspeler, maar zelfstandig kunnen werken;
  • uitstekende communicatief vaardigheden in de Nederlandse taal en Engelse taal.
Reactie

Geïnteresseerd? Stuur je curriculum vitae en motivatie, onder vermelding van referentienummer DO/18-005-DD, naar mevrouw Sandra van Putten van Derks & Derks B.V., info@derksenderks.nl.
Voor meer informatie kunt u bellen met Sandra van Putten via 033 – 4728087.

vacature sales-marketing

Open sollicitatie: Commerciële medische professionals

Aanbod
  • uitdagende posities binnen verschillende life science organisaties;
  • zelfstandige en verantwoordelijke functies van uitvoerend tot strategische niveau;
  • een detacheringcontract of samenwerkingsovereenkomst van Derks en Derks Detachering voor de looptijd van de opdracht.
Bedrijf

Derks & Derks Detachering is opgericht in 2007 en uitgegroeid tot een detacheringsbureau met evidence based personeelsoplossingen voor de farmaceutische, voedingsmiddelen en medische industrie. Onze relaties zijn actief op verschillende werkvelden en bijna allemaal internationaal georiënteerd. De meeste relaties hebben een lange historie binnen Nederland. Onze relaties zijn actief op zoek naar manieren, om de kwaliteit van leven van mens of dier ter verbeteren. Onze relaties zijn met enige regelmaat op zoek naar commerciële medische professionals, daarom komen vrij graag in contact met gedreven professionals.

Functie

Als commerciële medische professional ben je inzetbaar in de farmaceutische, voedingsmiddelen of medische industrie. Je hebt werkervaring opgedaan op het gebied van gebied van sales, marketing, market access of medical affairs binnen de genoemde branches. Je bent op de hoogte van de ontwikkelingen in de markt om de geneesmiddelen, voedingsmiddelen of medische hulpmiddelen beter te positioneren in de markt en hiermee de verkopen te verhogen. Je bent actief geweest op uitvoerend of strategische niveau en klaar voor een nieuwe uitdaging.

Profiel
  • minimaal een afgeronde hbo-opleiding;
  • ervaring in een uitvoerende en/of leidinggevend functie;
  • ervaring binnen de farmaceutische en/of voedingsmiddelen en/of medische industrie;
  • ervaring binnen sales, marketing, market access en/of medical affairs;
  • verantwoordelijkheidsgevoel met sterk kwaliteitsbesef;
  • teamspeler, maar zelfstandig kunnen werken;
  • uitstekende communicatief vaardigheden in de Nederlandse taal en Engelse taal.
Reactie

Geïnteresseerd? Stuur je curriculum vitae en motivatie, onder vermelding van referentienummer DO/18-006-DD, naar mevrouw Sandra van Putten van Derks & Derks B.V., info@derksenderks.nl.
Voor meer informatie kunt u bellen met Sandra van Putten via 033 – 4728087.

vacature techniek

Project Data Manager

Offer
  • a position to grow into or to deliver out of your experience
  • responsible for the supply chain business flows at an international project
  • a fulltime contract of 1 year, possibly longer
  • possibility to work from home or from the location in South Netherlands
  • project contract from Derks & Derks Secondment & Interim
Organisation

Our client is an international pharmaceutical company. The company’s activities comprise the development, production and sales of medicines. For the facility in Drenthe we would like to meet an enthusiastic, communicatively skilled, self-assured and performance-oriented Project Data Manager. 

Position

As a Project Data Manager you will be involved in the serialization project. The organisation uses a could bases solution to follow the products. For the products is it mandatory in many countries and the list of countries for Serialization is growing. Serialization follows strict rules prescribed by the Regulatory Authority of the Country of Sales.

The Project Data Manager will be responsible to ensure that proper data management is applied in the governance processes and data life cycle maintenance processes. You will be the pivotal point for conceptual developments and implementation of future Serialization requirements. A part of your role will be actively participating in various global Serialization initiatives, provide global perspective in Serialization decisions, data governance and management processes. The role is global in nature, collaborating with stakeholders (on business decision making level) in all regions and delivering on cross-regional responsibilities. The organisation is interested in a candidate that holds a natural interest in data governance where data standards, rules, ownership, quality, maintenance techniques, documentation and education need to be of the highest standard. You need to have a proactive attitude in knowledge collecting and sharing as well as communication. In line with this, business travel is required. Your reporting line will be to the Manager Master Data.

Profile
  • at least a bachelor’s degree or higher education in a relevant field
  • 5+ years of experience in a data management and or project management role, preferably within supply chain & manufacturing in the pharmaceutical industry
  • 3+ years of experience in coaching or managing staff
  • cemonstrated project management competences
  • prior contact with Serialization requirements would be considered a advantage
  • hands-on SAP experience gained in the Supply Chain and Master Data domain
  • ability to develop a vision to meet overall long term strategy
  • ability to work in a dynamic, volatile business environment
  • result-oriented, a key organizer and planner who clearly sets priorities
  • ability to work under pressure and manage a variable workload for the team
  • basic knowledge of GMP is preferable
  • good communication skills in the Dutch and English language
Response

Interested? Please send your resume and motivational letter by e-mail, with reference number DT/19-115-DD to Office@derksenderks.nl. For further information, please call Sandra van Putten at number +31 (0)33 472 80 87. An individual assessment may be part of the selection procedure.

 

vacature techniek

Product Data Manager/ Master Data

Offer
  • a position where your experience is recognized
  • working in international projects
  • a contract for at least one year
  • changes to growth is your knowledge
  • flexibility to work from different locations and from home
Organisation

Our client is an international pharmaceutical company. The company’s activities comprise the development, production and sales of medicines. They have several locations in The Netherlands where they looking to hire a new team member for the facility in Drenthe or Zuid-Holland. They would like to meet an enthusiastic, communicatively skilled, self-assured and performance-oriented Product Data Manager/Master Data.

Position

As a Product Data Manager/Master data you work together with a team. The team is responsible to provide and maintain high quality compliant master data that are available on time, in a consistent and controlled way. Thus, facilitating smooth execution of operational Supply Chain processes across the EMEA region. To own the Supply Chain Business Flows in EMEA SAP, you organize and manage the creation and maintenance of material master and master data aspects according the business scenarios and business rules. You also create and maintain material master data to support changes in existing business and introduction of new products and materials. You lead or participate in various projects where master data creation or change is involved. Due to various medium and large sized projects you create, update or delete material master data records. Additionally, some processes need to be changed. All the changes in processes and master data need to be documented by you. You will report to the Manager Master Data based in The Netherlands.

Profile
  • at least a bachelor’s degree or higher education in a relevant field
  • over 3 years of experience with Product Data Management or Master Data management
  • experience as (key) user of SAP
  • basic knowledge of GMP is a nice to have
  • profound knowledge of supply chain and manufacturing processes
  • good writing skills in English
  • good communication skills in English language
  • flexibility to work from several locations
Response

Interested? Please send your resume and motivational letter by email, with reference number DT/19-135-DD to Office@derksenderks.nl. For further information, please call Sandra van Putten 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.

vacature overig

Technical Writer Master Data

Offer
  • a position to grow into or to deliver out of your experience
  • responsible for the supply chain business flows at an international project
  • a fulltime contract of 1 year, possibly longer
  • possibility to work from several locations
  • temporary contract from Derks & Derks Secondment & Interim
Organisation

Our client is an international pharmaceutical company. The company’s activities comprise the development, production and sales of medicines. For the facility in Drenthe we would like to meet an enthusiastic, communicatively skilled, self-assured and performance-oriented Technical Writer Master Data.

Position

As a Technical Writer, you will be added to the master data team. The team is growing from a regional team into a global team. The current set of documentation requires to be rebuilt and made fit-for-purpose to the new ERP software solutions that are to be introduced over the next years.

As a Technical Writer, you will support the convert of the existing documentation supplemented with collected expert knowledge (through interviews) and available technical documentation in system user (e)-documentation such as procedures, instructions and training material. You will collaborate with the master data team to get a good understanding for their work processes and translate this into useful content for end users. You ensure output is consistent across product families and output formats. All together this is a challenging job where you can grow your knowledge of the Pharma sector with enough freedom to put your own ‘stamp’ on the output. In this job you will report to the manager of the department.

Profile
  • at least a bachelor’s degree or higher education in a relevant field
  • Supply Chain knowledge
  • interviewing skills augmented with user experience review and feedback
  • understanding of software tools used to create software product documentation
  • knowledge w.r.t. Master Data Management is preferred
  • proficient English writing skills
  • good document layout skills
  • basic business process design skills
  • profound Microsoft Office solution knowledge e.g. Word, Visio, PowerPoint,
  • SAP knowledge
  • ability to plan and manage multiple tasks
  • effective time management, good presentation skill and proactive approach
Response

Interested? Please send your resume and motivational letter by e-mail, with reference number DT/19-123-DD to Sandra van Putten: info@derksenderks.nl. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87. An individual assessment may be part of the selection procedure.

vacature productie

(Junior) Production Manager

Offer
  • quick development from operational to management tasks
  • great opportunity for good, energetic potential to grow into a management role
  • being part of a driven international organisation
Organisation

Our client is a repackaging company that works in close partnership with a German importer and distributor of EU medicines and diagnostics. They are a pharmaceutical wholesaler and importer of European medicines. In Groningen they a (re)packaging and labelling site which has now a team of 25 employees working there. To assure responsibility for the warehouse further coordinate and streamline their processes and to manage the staff on the site, we are looking for an ambitious Warehouse and Production Manager.

Position

In this position, you will start as a Warehouse Manager, and rapidly make the step towards Production Manager. You will have to lead the warehouse, its processes, and the team (4 fte), and as soon as you become Production Manager you will have an additional 8 fte to manage. Besides managerial tasks, you will mostly be a cooperating foreman. Planning and organizing incoming goods, distribution, and production are important aspects of your work. In the second phase, you become main contact point for the employees, are responsible for the schedule, staffing and performance interviews. Problems that occur on the shop floor will become yours to handle and solve, as well as working together with the Quality Manager when managing quality issues on the shop floor. Regarding quality issues, you will also cooperate with the Quality Manager in order to implement quality guidelines and principles.

Profile
  • higher vocational educational level
  • experience in a similar role preferred
  • minimum of 2 to 3 years of experience managing a Warehouse or Production department
  • knowledge of and experience with quality systems is desirable
  • decisive, vigorous, strong organisational skills
  • good social and communication skills
  • proficiency of Dutch and English
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WS/19-038-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.

vacature techniek

Maintenance Engineer

Offer
  • a dynamic and all-round position with broad opportunity for initiative
  • contributing to animal health in a unique production environment
  • operational tasks as well as management activities
Organisation

The company is powered by 50.000 employees globally. Learning and development for all employees is key, because their growth equalizes the growth of the company. The company creates value through innovation with one clear goal: to improve the lives of human and animal patients. The company develops breakthrough therapies, innovative healthcare solutions of unmet medical need. As a family owned company they focus on long-term performance. Currently, for one of their production locations with 30 employees, they are looking for a Maintenance Engineer to join them in their effort to make more animal health.

Position

As Maintenance Engineer you will provide and support technical support and management activities needed to make sure that uninterrupted and optimal operations run through production equipment and plant utilities. You will be part of a small team where you interact with everybody on site, you will have the liberty to be innovative in your way of working, and you have the opportunity to participate in international projects and take part to global working groups. Your tasks will consist of timely performing preventative and corrective maintenance of all equipment on the site for uninterrupted operation and ongoing compliance, investigation and elimination of root-causes of errors and failures. In addition, you will create, implement and monitor the annual long-term CAPEX plan, implement plant investment projects and personnel ideas (perform asset management). You will be responsible for ensuring the health and safety of direct reports, for demonstrating ‘safe behavior’ and maintaining the work permit system (height, heat and enclosed spaces) including LOTOTO procedure. You will be the contact person for external parties to arrange maintenance or changes, and cooperate with the Procurement department to negotiate pricing. You will also be responsible for ensuring GMP compliance of equipment and utilities and active participation in GoTrack modules (like deviations investigations, changes, CAPA, etc.). Furthermore you will support production (including training operators to changes in equipment) and assure technical training and development of the personnel of the technical department. In this position you will report to the Sight Director.

Profile
  • a degree in Engineering (hbo work and thinking level), at least 10 years of experience in a similar role
  • experience with biological processes/pharmaceutical industry and experience in leading projects
  • experience in process control; mechanical engineering, cleaning and sterilization processes, electrical processes
  • familiar with a GMP environment
  • affinity with SAP
  • excellent command of the English and Dutch language
  • team player, stress resistant, hands-on, good communication skills and able to explain technical challenges to non-engineers
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WL/19-039-DD, to Sophie van Baalen: info@derksenderks.nl.

For further information, please call Sophie van Baalen 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.

vacature overig

Recruitment Consultant voor vaste en tijdelijke functies (0,8 – 1,0 fte)

Aanbod
  • werken in een succesvolle en groeiende dienstverlenende organisatie;
  • een enthousiast team van collega’s;
  • open cultuur en sfeer, waardoor je waarschijnlijk snel je plek zal vinden binnen het team;
  • breed takenpakket met grote mate van verantwoordelijkheid;
  • ruimte voor opleiding en ontwikkeling;
  • samen met collega’s verantwoordelijk zijn voor het resultaat;
  • op of uitbouwen van een netwerk binnen de life sciences en gezondheidszorg;
  • gunstige pensioenregeling;
  • salaris dat past bij de ervaring en het eventuele netwerk dat je meebrengt.
Bedrijf

Derks & Derks brengt als strategisch partner in human talent, organisaties en hoger opgeleide talenten in Life Sciences en gezondheidszorg samen. Werving & Selectie, Detachering & Interim, Talent Development, HR Research en Opleiding & Training vormen de kern van onze dienstverlening. Persoonlijke aandacht, heldere afspraken, integriteit en strikte kwaliteitsnormen, vormen daarin altijd de basis. Met een breed netwerk en sterke vak- en branchekennis, zijn wij dé strategisch partner in human talent.

Om onze rol als specialist in Life Sciences steeds breder in te vullen en in te spelen op marktontwikkelingen, hebben we de afgelopen jaren diverse innovatieve projecten in deze markt gelanceerd:

  • Masterclass NieuweZorg (verheldering en verdieping voor iedereen die meer wil betekenen voor de zorg)
  • Leergang Industriële Farmacie (praktijkgerichte professionalisering in de farmaceutische industrie)
  • FMF-vacatures (alle HBO+ vacatures in Life Sciences online beschikbaar)
  • INRALS (internationaal netwerk van werving- & selectiebureaus in Life Sciences)

Onze kernwaarden zijn: samen het beste resultaat, team van experts, betrouwbare partner en kwaliteit verzekerd. De cultuur is hands-on, klantgericht, informeel en betrokken. Er wordt hard gewerkt, maar ook veel gelachen. Om ons team van experts uit te breiden zijn we op zoek naar een gedreven, professionele en enthousiaste Consultant, die graag bijdraagt aan de gezamenlijke doelstellingen van de afdeling.

Functie

In de functie van Consultant ben je gesprekspartner voor onze opdrachtgevers en professionals op zoek naar een nieuwe uitdaging. Aan jou de taak om te zorgen voor de juiste match. Je helpt de professional met het vinden van de juiste baan en eventuele vervolgstappen in zijn/haar carrière binnen de branche. Tevens ben je strategisch partner voor de opdrachtgevers waarvoor je werkt. Je adviseert, waar mogelijk bij HR gerelateerde vraagstukken, of informeert over de andere ondersteunende diensten en opleidingen van Derks & Derks. Je moet snel kunnen schakelen en meerdere ballen in de lucht kunnen houden. Je takenpakket bestaat onder andere uit het op- en uitbouwen van nieuwe en bestaande relaties, opstellen van plan van aanpak, coördineren van opdrachten, schrijven van wervende vacatureteksten, searchen en interviewen.

Profiel
  • hbo/wo werk- en denkniveau;
  • bij voorkeur ervaring in vergelijkbare functie, kennis van recruitment (branchekennis is niet vereist);
  • representatief, proactief, daadkrachtig, mensgericht en betrokken;
  • commerciële instelling;
  • verbinder, weet de juiste match te maken;
  • goede beheersing van Nederlandse en Engelse taal;
  • gezonde dosis humor.
Reactie

Geïnteresseerd? Stuur je curriculum vitae en motivatie, onder vermelding van referentienummer WL/17-131-DD naar Sandra van Putten, info@derksenderks.nl. Voor meer informatie kun je contact opnemen met Sandra of Pieter via 033 – 4728087. Een assessment maakt deel uit van de selectiemethode.

vacature overig

EMEA Business Controller

Offer
  • a position where your experience is recognized
  • working in international projects
  • a contract for at least 12 months
  • changes to growth is your knowledge
  • flexibility to work from different locations and from home
Organisation

Our client is an international pharmaceutical company. The company’s activities comprise the development, production and sales of medicines. They have several locations in The Netherlands and are willing to hire a new team member for the facility in Drenthe or Zuid-Holland. They would like to meet an enthusiastic, communicatively skilled, self-assured and performance-oriented Business Controller for the EMEA region.

Position

As a Business Controller you cover EMEA Trading entities (APEBV, ADE and APEL) and your focus is towards APEBV, as a trading company and the IP holder within the APEBV legal entity. Tasks will be associated with Financial Accounting, Management Accounting, Compliance (Financial and other), logistics, financial systems and process duties for all activities concerning the sale of product and in the capacity as IP Holder.

In this role it is your responsibility to conduct more complex elements of financial/management accounting, JSOX compliance, logistics, and process duties for activities concerning the sale of products to EMEA affiliates and 3rd party distributors. You provide commercial oversight to ensure appropriate governance and that transactions flow in accordance with API’s Tax & Transfer Pricing strategy and with EU tax legislation. You work collaboratively across a number of functions (including Other Group Trading & IP Holder Companies, API Finance, EUTD, Commercial Finance, EMEA Business Services). Also, it is your responsibility to operate as an effective Finance Business Partner to internal and external stakeholders. You collaborate to make effective decisions and to add business value where possible. You deliver timely and accurate financial reporting, both internally and externally. Furthermore, you apply initiative and commercial judgement to resolve problems, making timely decisions to support time sensitive commercial goods and services movement. Last but not least you work collaboratively as a member of the Finance team, contributing to overall performance. In the role you report to the Director Trading EMEA.

Profile
  • bachelor or Master degree in an accounting or equivalent
  • experience in a similar position as a Business Controller in a international environment
  • demonstrable experience in the end to end financial administration process
  • specific knowledge of inventory financing is a must have
  • must have experience of working across multiple sites and localities
  • experience with SAP and MS office
  • full command of written and verbal business English
Response

Interested? Please send your resume and motivational letter by email, with reference number DT/19-147-DD to Office@derksenderks.nl. For further information, please call Sandra van Putten at number +31 (0)33 472 80 87. An individual assessment may be part of the selection procedure.