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Application Manager QMS @Bilthoven Biologicals
Bilthoven
Euro 3986 - 6095 per maand
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Bedrijfsprofiel – Company profile
Bilthoven Biologicals (BBio) is een internationaal biofarmaceutisch productiebedrijf. Met ongeveer 500 collega’s produceert BBio vaccins, zoals polio, difterie-tetanus-polio (DTP) en BCG. BBio levert vaccins aan organisaties waaronder de Wereldgezondheidsorganisatie (WHO) en UNICEF, en draagt zo bij aan het mondiale programma om polio uit te roeien. BBio maakt deel uit van de Poonawalla Group, eigenaar van het Serum Institute of India, de grootste vaccinproducent ter wereld. BBio investeert in de modernisering en uitbreiding van hun productiecapaciteit.
And most importantly: BBio is a growing company. This offers opportunities for ambitious people. Don’t expect a bed of roses, but do expect the chance to grow with BBio.
And most importantly: BBio is a growing company. This offers opportunities for ambitious people. Don’t expect a bed of roses, but do expect the chance to grow with BBio.
Samenvatting – Summary
As an Application Manager QMS, you play a key role in optimizing and managing BBio’s QA platform within the pharmaceutical environment
Omschrijving – Description
Job Vacancy: Application Manager QMS
As an Application Manager QMS, you play a key role in optimizing and managing BBio’s QA platform within the pharmaceutical environment. You are responsible for the functional and also technical management, further development, and ensuring compliance of the QA application as an important system in our organization. With your knowledge of applicationmanagement preferably QA systems and again preferably within pharmaceutical regulations (GxP, GMP), you ensure that BBio’s processes are efficiently, safe, and future-proof designed. The QMS software used by BBio is Veeva.
Main tasks and responsibilities:
The Ideal Application Manager QMS:
As an Application Manager QMS, you play a key role in optimizing and managing BBio’s QA platform within the pharmaceutical environment. You are responsible for the functional and also technical management, further development, and ensuring compliance of the QA application as an important system in our organization. With your knowledge of applicationmanagement preferably QA systems and again preferably within pharmaceutical regulations (GxP, GMP), you ensure that BBio’s processes are efficiently, safe, and future-proof designed. The QMS software used by BBio is Veeva.
Main tasks and responsibilities:
- Translating business requirements into functional and technical solutions within Veeva.
- Actively contributing to implementations, upgrades, and integrations with other systems.
- Ensuring compliance with relevant regulations (e.g., GxP/GMP, validation requirements).
- Analyzing incidents and performing necessary activities for and resulting from periodic reviews of the application, in accordance with GxP/GAMP5/ISO guidelines.
- Preparing and maintaining documentation (SOPs, work instructions, validation reports).
- Serving as a point of contact and sparring partner for internal stakeholders such as QA, Regulatory Affairs, and IT.
The Ideal Application Manager QMS:
- Completed Bachelor’s degree, preferably in Computer Science, Business IT & Management, Pharmacy, Life Sciences, or equivalent.
- Strong analytical skills and ability to translate business needs into IT solutions.
- Relevant expertise in application management and change management.
- Preferably relevant experience as an application specialist of a QMS, preferably in the pharmaceutical or life sciences sector.
- Preferably good knowledge of GxP/GAMP5 and experience with system validation.
- Excellent communication skills in English and preferably also in Dutch.
Aanbod – Offer
What Bilthoven Biologicals offers:
- Salary in scale 9 or 10 (between €3,986 - €6,095 gross per month, based on 40 hours per week) depending on your knowledge and experience.
- An end-of-year bonus (13th month) and a good pension scheme.
- A contract for 32 to 40 hours per week.
- A dynamic, socially driven work environment.
- A good travel expense allowance.
- A declaration of conduct (VOG) is part of this application procedure.
