WHAT ARE YOUR RESPONSIBILITIES?
- Assure that products manufactured and packaged company and legal requirements.
- Assure that products purchased and used in the Puurs plant meet company and legal requirements.
- Investigate batches not meeting specifications and prepare recommendations to the QA Manager/QA lead.
- Coordinate cross functional investigations in case of complex root causes and work closely with Manufacturing Operations and supporting departments.
- Evaluate root cause analysis, corrective and preventive actions and verify effectiveness in order to prevent recurring deviations.
- Evaluate incidents that occur in the facility of your area and prepare recommendations to the QA Manager/QA lead.
- Operate and maintain the Quality Assurance systems.
- Review batch related manufacturing documentation for conformity.
- Approve master documents and SOP's.
- Prepare Annual Product Reviews and Quality Performance Review.
- Prepare necessary release documentation for your area.
- Design the test plans for products in your area.
- Support continuous improvement of products and processes through:
- Quality deviation investigation (events/QAR's).
- Participation in operations, product and system teams and Daily Operations Review meetings.
- Contribute to timely supply of products.
- Release authority:
- Product batches that meet Company and legal requirements (PQS, GMP etc).
- Every Quality Assurance Report (QAR) needs to be approved by the Quality Assurance Lead, Manager QA, SQOL or Opu QL as described in the effective SOP.
WHO ARE WE LOOKING FOR?
- You have a master degree with scientific background: (industrial) pharmacist, bio-engineer, industrial engineer, biomedical,…
- You have experience in a manufacturing environment or packaging environment
- You have experience with quality investigations and release of biological products or vaccines
- You have Analytical skills
- You have good communication skills, verbal and in written, in Dutch & English
- You have good time management and prioritizations skills
- You have human interactions (diplomacy, convincing, assertiveness, …)
WHAT DOES QBD OFFER YOU?
- A young and dynamic company with a feel good culture, and a great openness and a no-nonsense approach
- Real investment in people through education and fun events
- A competence development model focused on your personal ambitions
- An attractive salary package
- Interested? Apply now by sending us your CV and motivation.