A great opportunity for a motivated GMP Change Control Specialist to join a leading Biopharma in Leiden.
In this role you will be responsible for the well-structured approach and the progress of GMP Change Controls. You will be the first line support of the Change/Project Lead, coordinating and facilitating Change meetings and ensuring that progress is documented in a compliant way. Additionally, you will also work on maintenance and improvement of general GMP processes, as needed. You collaborate closely with the operations department, the equipment owners and the process engineers and other staff members of the VF.
- Writing change controls for the GMP/ EHS systems and VF improvements, and responsible for follow up and timely documentation and completion;
- Keeping general VF GMP documentation up-to-date;
- Support in improvements on production processes and systems within the VF;
- Support lead deviation investigation in documenting product impact analysis and root cause investigation and timely follow up (including CPA records) and completion;
- Training coordinator and responsible for the training-syllabi within the VF;
- Coordinator of documentation periodic review within the VF; support internal batch release.
- Working precisely, detecting, and solving acute problems and communicate possible abnormalities;
- Leading process excellence activities to continuously improve the work as well as personal skills.
- Note: In general, the associate role will typically have ownership on less complex GMP roles and supports the GMP specialists in complex issues or priority projects.
- Bachelor’s degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
- 2 years relevant work experience in a biotechnology or biopharmaceutical industry environment or Technical background (TU)
- Experience in Quality Systems, specifically Change Control
- Working knowledge with cGMP standards
- Preferably experience with Trackwise QEM, Docspace or similar automated systems
- Fluent in English
- 1 years (high chance of extension)
If you are interested in the above description, apply with your CV
PS: Did you also know that we offer an attractive referral scheme?
For further information, please contact Aimee Brenner at +31 (0)20 20 44 502 or by email at email@example.com