The GMP specialist is responsible for GMP related items in BU5 and supports the BU5 organization with specialized and in-depth knowledge and skills on the GMP processes, systems and compliance. This role requires the ability to devise effective solutions while collaborating and aligning with various stakeholders.

The GMP Specialists are integral members of the broader Centre of Expertise (CoE) department. The CoE is crucial in supporting both the Operations (Ops) and New Product Introduction (NPI) departments, particularly regarding technical processes and GMP compliance (including Annex 1).The CoE plays a key role in translating the developed process to a workable process and environment for the shop floor. The CoE always works against the high-quality standards, safety and compliance regulations that are applicable for LVV manufacturing.

Roles and responsibilities

Review general LVV GMP documentation and delegate improvements to keep the general GMP compliance up to date.
Write and facilitate change controls to document introductions and changes in the GMP production processes.
Leads deviations and root cause investigations and ensures a timely follow up and completion of the non-conformance records.
Participating/facilitate in quality risk assessments (QRA).
Coordinating, supporting and preparing activities during internal and external audits in the role of Primary Contact, SME, scribe, or back-office lead.
Coordinator internal batch release.

Functie-eisen

Bachelor or University degree in preferably Science or Engineering.
2-8 years experience in a biotechnology or biopharmaceutical (GMP) production environment.
Strong working knowledge of current Good Manufacturing Practice (cGMP) standards is essential. Familiarity with Annex 1 regulations is preferred.
Experience with the use quality systems (E.g. Comet, TruVault).
Experience with the following Microsoft tools: Excel, Visio, SharePoint, Word and PowerPoint.
Excellent communication skills in English, additional Dutch is preferred.

Competenties

Influencing skills,
excellent stakeholder management within a high complex matrix organization

Arbeidsvoorwaarden

Discount on the collective health insurance scheme via Zilveren Kruis
Access to the YACHT network of companies and industry specialists
A favorable pension scheme (STIPP)
8 % holiday allowance
Good travel allowance of €0.21 per km
Training budget provided by Yacht: €3,500 per year
A one-time home office allowance of €750
Soft skills coaching

Location: Sassenheim, Netherlands - Hybrid working - 3 days a week on site

Duration: 12 months

Bedrijfsinformatie

The Lenti Viral Vector Facility: Janssen Biologics B.V., part of Johnson & Johnson, is setting up a new production facility in Sassenheim. This new facility will produce lentiviral vector (LVV), which is used in the treatment for multiple myeloma, a disease affecting 160.000 patients globally. The project team is preparing to get ready for commercial production in 2025.

Randstad Life Sciences

Randstad is a leading Dutch recruitment and secondment agency that connects highly qualified professionals with forward-thinking organizations. As part of Randstad Group Netherlands, Randstad Life Sciences is a premier talent partner in the Dutch Life Sciences, Pharma, and Biotech sectors. Yacht places ambitious professionals in meaningful roles at top-tier organizations such as Astellas, Danone, Philips, and Johnson & Johnson.

In one of the fastest-growing sectors in the Netherlands, Yacht Life Sciences offers both project-based assignments and permanent positions that contribute to the development of medical devices, therapies, and medicines aimed at improving global health.

Professionals partnering with Randstad benefit from:

Access to a robust network of industry experts and innovative companies
Opportunities to participate in R&D projects, clinical trials, and quality & regulatory initiatives
Continuous development through training, courses, and knowledge-sharing sessions
A personalized career path shaped by your ambitions and supported by dedicated coaches and consultants

Contactinformatie

Apply now and you will receive a WhatsApp message within 15 minutes with a few short questions, so we can help you quickly. Don’t have WhatsApp? No problem, we will contact you via phone or email!

For more information, please contact Nicole Miggels at 06-13897074.

Uiteraard staat deze vacature open voor iedereen die zich hierin herkent.

contact

Nicole Miggels
nicole.miggels@randstadprofessional.nl
06-13897074

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GMP Specialist
Randstad Professional

functieomschrijving