We are currently seeking an experienced Qualified Person in GMP. Are you interested in working at a state-of-the-art pharmaceutical company as a QP? Please continue reading and apply now!
Job Description
At an innovative pharmaceutical company, we have a position available as a Qualified Person (QP). For this role, we are looking for someone with prior experience in a similar role or an experienced QA person that would like to become a QP.
As a QP, you will work in a small team and carry significant responsibilities. In addition to strong technical knowledge, excellent communication skills are essential, as you will be the point of contact for internal and external stakeholders regarding audits and quality. You will have the ultimate responsibility for ensuring the certification of all products entering the market. Thanks to you, all products in the sales pipeline will be appropriately certified for quality, and more. If you are familiar with this role and are seeking a new environment to further expand your knowledge, we invite you to respond promptly to this vacancy.
Responsibilities:
- Batch certification and release of pharmaceuticals.
- Working on marketing authorization/IMPD, in compliance with applicable EU guidelines.
- Investigating deviations in close collaboration with the deviation specialist and approving/finalizing deviations.
- Approval of Change Controls.
- Acting as a liaison for regulatory authorities (IGZ, Farmatec, PEI) to maintain compliance status.
- Participation in R&D project teams as a quality representative.
- Approval and execution, including follow-up on internal and external audits.
- Providing support for quality-based decision-making processes.
Requirments:
- Academic degree, preferably in pharmacy or a related field.
- Qualified as a Qualified Person by IGZ.
- Minimum of 2 years of work experience as a QP or experienced in QA.
- Excellent knowledge of pharmaceutical processes such as R&D, QC, and production.
- Experience with the implementation and maintenance of quality management systems.
- Audit experience and strong communication skills.
- Proficiency in English.
Benefits:
- Employment type: Initially a one-year contract, with the intention of a permanent appointment.
- Salary range: €5000 to €7300 per month, excluding the 13th month.
- Working hours: Part-time or Full-time.
- Location: Leiden.
- Job number: 23513.
