vacature kwaliteit

Open sollicitatie: GxP professionals

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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 regulatory-affairs

Regulatory Affairs Manager

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Offer
  • a challenging and fast-growing organisation
  • family culture where everyone makes a collaborative impression
  • a role where you need your knowledge to help the growth
  • great abilities for a personal grow
  • good salary package
Organisation

The organisation is a (bio)pharmaceutical company based in Noord-Brabant. They are currently facing the next stage of the clinical phase where they need to expand their team with another expert. Therefore the organisation is looking forward to get in touch with a flexible and collaborative Regulatory Affairs Manager.

Position

In the position of Regulatory Affairs Manager you will have the basic responsibility to ensure that the organisation has an established, maintained, comprehensive and efficient global regulatory strategy that aligns pharmaceutical product development timelines, product authorisations and budget. Other responsibility will be that you maintain good contacts with global competent authorities and that you will write and maintain IMPD for all products. You will coordinate writing and approval of regulatory required documentation. But you will also coordinate regulatory submissions. Furthermore you will be responsible for review and approval of the rationale and regulatory impact assessment related to any potential (substantial) changes to the product, manufacturing process, analytical methods of our products under the Pharmaceutical Quality System. You will act as the regulatory point of contact for external partners, companies, or organisations for product related regulatory questions. You will inform potential (upcoming) ATMP regulatory or guidance document changes which may impact product development and authorisations. Overall you will be responsible for product approval timelines coordination. Next to this you will also be creating extra awareness for regulatory by sharing your knowledge with others and even train others. In the role you will work closely with the QA/QP manager and the team. You will report to the Director Operations.

Profile
  • at least a bachelor’s degree
  • over 5 years of regulatory experience within ATMP
  • working experience in the industrial (bio)pharmaceuticals
  • ability to implement complex regulatory details in a simple strategy while adhering to relevant regulations
  • good written and oral skills in English
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WL/19-073-DD, to Sandra van Putten: info@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 klinisch-onderzoek

Digital Clinical Data Manager

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Offer
  • a challenging job within a global healthcare company
  • an operational role in an international environment
  • a temporary contract till the beginning of December
Organisation

Our relation is international active in the healthcare industry. They produce and sell their products to the international market. They are always looking for new innovative medical device products by investing in research and development. With this investment they hope to stay on top of the market. They design the product trough the eyes of the end user combined with an appealing design. The organisation is always looking for improvement of there processes. Therefore, they like to get in touch with a Clinical Data Manager.

Position

The organisation is a new business within the venture organization. The venture is tasked with developing a new “software only” product called IntelliSpace Cognition. This new product is a class II medical device. In the position of Digital Clinical Data Manager, you will conduct source data verification by checking data for accuracy and completeness. You will optimize the collaboration between data owners and domain experts. Furthermore, you are exporting and organizing data from our product database and developing a long-term data management strategy. Reviewing and cleaning research data will also be a task in the position. You will also prepare data files for analysis in close contact with other team members and provide insightful data overviews for clinicians, researchers and software developers. Next to this you will create interfaces and dashboards to gain deeper insights into the performance of the products. In the position you will report to the manager of the department.

Profile
  • work experience or degree that supports clinical data management
  • a “go do”, self-propelling attitude to work
  • ability to interact with people in both the scientific, clinical and technical (SW) worlds
  • affinity to work with clinical data and ability to develop software independently
  • solid knowledge of at least one programming language (R or Python preferred)
  • knowledge of Postgres databases is a plus
  • knowledge of Good Clinical Practice
  • accurate and an eye for detail
  • good written and verbal English skills
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/19-124-DD, to Sandra van Putten: info@derksenderks.nl.
For further information, please call Sandra van Putten at number +31 (0)33 472 80 87.

vacature sales-marketing

Open sollicitatie: Commerciële medische professionals

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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 kwaliteit

Quality Manager

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Offer
  • working in an international environment
  • dynamic and challenging role
  • good secundaire benefits
Organisation

Our client is a supplier of high-quality medical products. They specialise in products for wound, continence, diabetes and acute (first aid) care. They offer a wide range of brands, including their own. These products have been developed on the basis of the latest insights and developments in healthcare. They are a dynamic and fast-growing company with 50+ employees. Our client has an open, informal culture with short lines of communication. Hard work go hand in hand with solidarity and a pleasant working atmosphere. This position is based in Venray.

Position

As a Quality Manager you will work in close cooperation with all departments in the company and with our client suppliers and distributors. In this role you will be responsible to guarantee the quality policy of the company. You will ensure that this policy is understood, implemented and maintained at all levels of the organisation while complying with the applicable regulatory requirements. Besides this you will assess the regulatory requirements for new products, define the regulatory strategy, manage regulatory submissions and obtain approvals in a timely manner. Other tasks may include setting up and coordinating supplier improvement quality performance programs and performing audits and providing audit support both internally and with suppliers and distributors. As a Quality Manager you will report to management on the implementation and effectiveness of the quality management system and identify needs for improvement. Besides this you will prepare and maintain clinical evaluations and post market surveillance reports.

Profile
  • bachelor’s or master’s degree in life science or engineering area
  • preferably minimum of 5 years’ experience in EU regulations/ standards related to wound, continence, diabetes and acute (first aid) care
  • experience leading and facilitating audits
  • results and customer oriented, rigorous, autonomous and flexible
  • knowledge and experience of medical devices, MDR and ISO 13485
  • strong oral and written communication in Dutch and English
  • great organisational skills and a ‘getting things done’ attitude
  • self-learner
  • preferably located in Venray (NL) area
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WL/19-063-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 kwaliteit

QP Biotechnology

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Offer

  • an innovative, fast growing, biotechnology company
  • a role where your knowlegde is welcome
  • a permanent contract, starting with a 5 months contract

Organisation

The organisation is a Biotechnology company focused on cellular Immunotherapy in clinical stages. Recently they develop a new method to make cancer a chronic disease and they can use some help. Our client is located in The Netherlands and has about 50 employees that think globally. They are ambitious and believe in their product. To expand their team they are looking for someone like them, always striving for the best. Currently they are looking for an Interim QP.

Position

As Interim QP your role entails a broad range of duties and the specific areas of focus will be dependent on the skills and experience of the person holding the role. The basic responsibility is to ensure that our cell and gene therapy products are manufactured and released according to quality guidelines, regulatory requirements and trial needs. You provide guidance and direction to Development, Production and Quality staff regarding compliance with quality standards and procedures.

You will be responsible for ensuring that each individual batch has been manufactured and tested in accordance with the requirements of the IMPD and the applicable GMP regulations. Also you are responsible for batch disposition (e.g. GMP-release) of the batches produced. You are involved in the set-up and validation of the manufacturing process, analytical methods and specifications. In addition to the QP role and responsibility the QP will help and assist with Document control, Deviation and CAPA system management but also Product complaints, returns, and recalls. Furthermore you give the Vendor approval, qualification and management and make round regarding the Internal (self-inspections) / external audit program. In this role you will report to the Chief Regulatory/Quality Officer with the obligatory dotted line into the CEO.

Profile

  • Sc. or PhD degree in pharmacy, biotechnology, biology or equivalent
  • experience in QP-related functions
  • experience working in a GMP regulated environment
  • experienced in biotech products where experience with Advanced Therapy Medicinal Products (ATMPs) is preferential
  • knowledge of biotech production processes
  • knowledge of sterile production processes
  • knowledge of GMP quality systems

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/19-111-DD, to Sandra van Putten: info@derksenderks.nl. For further information, please call Sandra van Putten at number +31 (0)33 472 80 87.

vacature kwaliteit

Quality Engineer

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Offer
  • working in an international environment
  • dynamic and challenging role
  • good secundaire benefits
Organisation

Our client is a supplier of high-quality medical products. They specialise in products for wound, continence, diabetes and acute (first aid) care. They offer a wide range of brands, including their own. These products have been developed on the basis of the latest insights and developments in healthcare. They are a dynamic and fast-growing company with 50+ employees. Our client has an open, informal culture with short lines of communication. Hard work go hand in hand with solidarity and a pleasant working atmosphere. This position is based in Venray.

Position

As a Quality Engineer you will be part of the Quality Department and report to the Quality Manager. You work closely together with the Product Managers. You will be responsible for the preparation and maintenance of the technical files in support of CE marking of existing and new medical devices. Besides this you will assess the production methods and quality processes at suppliers and distributors. You will make root cause analyses through quality data analysis and failure analysis process and implement the corrective and preventive actions. Other tasks may include performing internal and external audits of products and (production)processes and executing the post market surveillance plan. Besides this you will demonstrate compliance of the quality processes during audits and inspections by our clients Notified Body, customers and regulatory authorities.

Profile
  • bachelor or master with minimum 3 years’ experience
  • experience with the medical device sector in wound, continence, diabetes and acute (first aid) care is a plus
  • trained and knowledge of process and product audits
  • experience with ISO13485 and medical devices regulation
  • good analytical and logic deduction skills, problem solver
  • good communication and negotiation skills
  • strong oral and written communication in Dutch and English
  • preferably located in Venray (NL) area
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WL/19-064-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

Project Lead Technology & Serialization

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Offer

  • a versatile and challenging job in a dynamic work environment
  • a place where you can share you knowlegde
  • good primary and secondary working conditions
Organisation

Our client is active worldwide in the development and production of commercial and clinical packaging materials. They have multiple offices and production locations around the world, employing around 1,800 people every day. For the location in Belgium they are looking for an experienced and enthusiastic Project Lead Technology & Serialization.

Position

As a Project Lead Technology & Serialization you will be responsible for running multiple projects within the organsation. Your first priority is to lead the serialization project by implementing and continuously evaluate the European serialization approach. You lead, coache, guide, evaluate and assign the serialization team members. Notice that those team members are across European sites. You will be responsible for the creation, implementation and monitoring of the serialization vision and architecture for the European (commercial) organization. You will oversee the complete serialization portfolio. Next to this it is your responsibility to guard and report the project process, ownership, progress, budgets and invoicing over the projects organization wide. Furthermore you coordinate, monitor and report serialization packaging projects within timelines, budget, resource consumption and scope included changes. You identify the project risks early stage and mitigate/control/escalate them appropriately. As mentioned at the beginning of the description this is the first project that you will lead. Besides this project there will be more upcoming.

Profile
  • Master level of education
  • more than 5 years of experience in Project management and Technology
  • specific experience with running a European serialization project
  • experience in leading mutidisciplinary project teams
  • affinity with IT systems
  • experience with MS Project and MS Office
  • GMP knowledge
  • fluent in both Dutch and English (spoken and written)
  • willing to travel within Europe
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WL/19-062-DD, to Sandra van Putten: info@derksenderks.nl. For further information, please call Sandra van Putten at number +31 (0)33 472 80 87.

vacature overig

Software Quality Assurance Engineer

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Offer
  • a challenging job within a global healthcare company
  • an operational role within an international environment
  • a temporary contract until the end of the year
Organisation

Our client is international active in the healthcare industry. They produce and sell their products on the international market. They are always looking for new innovative medical device products by investing in research and development. With this 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 like to get in touch with a Software Quality Assurance Engineer.

Position

The Software Quality Assurance Engineer role is a vital organizational component ensuring regulated automated tools used in the Quality System are appropriately validated and controlled through their life cycle from development, deployment, change control and retirement. This includes ensuring project teams adhere to processes and control mechanisms for software, hardware, data and relevant security to meet regulatory requirements.

In this role it is your responsibility to enforce policies and procedures for System Life Cycle control for use in Healthcare across all automated processes that drive, interface with, and provide data for the Quality System. You will support development of the validation strategy and the validation effort from planning to retirement of Q&R systems and tools including interfaces to and from the system. You will also give support to regulatory and internal audits just like providing subject matter expertise during regulatory and partner inspection. You will provide software quality assurance support in design and development of software solutions, and facilitate the application of controls and risk management by reviewing and approving IT change-control requests submitted by cross-functional project teams to assess potential quality system impact. You ensure that system development projects and changes to existing systems are conducted in compliance with the FDA Quality System Regulation and Medical Device Directives. It is a challenging job with a wide responsibility to the Quality System. You will report to the manager of the department.

Profile
  • at least 7 years of experience in validation of computer systems and systems security and control including supervision of a technical professional staff
  • experience working in disciplined regulated industry in the application of automated technology particularly 21 CFR, ISO 13485, GAMP 5
  • multiple years of experience with computerized systems implementations, comprised of multiple application types, in a regulated environment
  • demonstrated ability to interact and communicate (both oral and written) with junior project team/ organizational members, business leaders and senior executives.
  • expertise in IT protocols related to software/hardware validation, information security, data lifecycle management
  • understanding of current inspectional practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessments or inspections
  • ability to apply current inspectional techniques to project documentation during the system lifecycle and prior to FDA inspection to ensure a comprehensive documentation package is created and maintained.
  • effective judgment and decision making skills, typically made under stressful situations
  • competency in project management and the execution of multiple projects
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/19-149-DD, to Sandra van Putten: info@derksenderks.nl. For further information, please call Sandra 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.

vacature overig

EMEA Business Controller

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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.