Microbiologist - Quality - Biopharmaceutical

An exciting contract opportunity has arisen for an experienced Microbiologist to join a state-of-the art biopharmaceutical manufacturing facility based in The Netherlands.

With products produced in their own production facility meeting the highest standards, the products are also produced for external parties.

THE ROLE:

As Microbiologist Quality Officer you will joint the QC Project & Stability Department, and will be responsible for developing microbiological methods (bioburden and sterility) for various samples according to Ph. Eur. And USP monographs and writing development reports.

This will involve checkingwriting (risk) assessments;
- Provide support for validations of microbiological systems (equipment).
- Troubleshooting and Ad Hoc Issues/OOS/Events, etc. at the lab
- Writing validation protocols and reports for microbiological analysis methods according to guidelines (Bioburden and Sterility);
- Co-ordinate the execution of analyses for validation/verification;

EXPERIENCE REQUIRED:

- KNOWLEDGE OF MICROBIOLOGICAL METHODS (BIOBURDEN AND STERILITY)
- Experience with GMP, and validation guidelines;
- Experience with knowledge transfer to colleagues through, among other things, giving presentations, training and working new users
- Demonstrable HBO work and thinking level;
- Experience in the pharmaceutical industry;
- familiarity with GMP, Pharmacopoeia and validation guidelines;
- has the ability to analytically handle complex microbiological issues;
- Has experience with knowledge transfer to colleagues through, among other things, giving presentations, training and working new users;
- Independent and proactive setup, service-oriented setting and flexibility: the customer center;
- possesses perseverance and conviction;
- be able to report clearly;
- hands on mentality;
- Good command of the English language in word and writing;
- An enthusiastic, disciplined and quality-oriented employee with relevant training and natural seniority.

THE DEPARTMENT:

The QC-Projects & Stability Department is responsible for setting up new analysis techniques (developing and verifying/validating) existing products and for new products (including for external parties), troubleshooting ad hoc issues/OSD etc. at the lab and Managing the stability program.

Lovely company - Excellent location!