The Qualified Person (QP) certifying the finished product is responsible for ensuring that each finished medicinal product batch has been manufactured in accordance with GMP, the terms of the MIA (Manufacturing and Import Authorization), and the MA (Marketing Authorizations). Also included is the responsibility of the release of blood plasma and all further intermediates according to Annex 14
Your job:
- Perform EU QP certification for all products under Prothya Biosolutions B.V. responsibility including products of contractpartners
- Ensure Quality Compliance with all National and International Regulations and internal company regulations
- Oversight of QMS (Quality Management Reviews), which includes Quality Management Reviews, Quality Agreements, Product Quality Reviews
- Maintenance of the Manufacturing License
- Approve Product Quality Complaints related investigations
- Cooperate with all necessary departments to ensure that communication to the Authorities is appropriate, coordinated and approved
Your profile:
- Pharmacist/ MSc in Pharmaceutical Sciences or one of the following scientific disciplines: Biopharmaceutical Sciences, Medicine, (Bio-)Chemistry or Biotechnology or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
- A minimum of 5 years of experience in the healthcare/pharmaceutical industry (Production, QC-labs)
- Experience as a QP in the biotech or pharmaceutical manufacturing industry
- Persuasiveness and decisiveness
- Clear communicator
- Shows sense of urgency and sensitive for the needs of the organization
- Excellent writer
- Fluent in Dutch and English
- Availability for 36-40 hours per week
- Ability to work on-site for minimal 3 days per week
Our offer:
We offer you a fulltime position with the following employment conditions:
- A market-rate salary
- A budget of 16,66% (holiday allowance and year-end bonus) of your gross salary, yours to spend or to save monthly
- A fulltime employment of 40 hours per week
- Flexible working hours after deliberation
- Your own place in a close-knit and expert team with an employer that stimulates growth and personal development
- Good accessibility by public transport and we provide private parking;
- Sound pension provision.
