For a client in the region of Bornem/Puurs we are looking for a Release Engineer
Did you obtain a university degree in a scientific field?
Did you have a first experience in a manufacturing environment?
Then you are the junior profile we are looking for! Don't hesitate to apply or ask for more information.
Assure that products manufactured and packaged on the site and by Third Party Manufacturers plant meet Company and legal requirements and assure that products purchased and used in the 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 cause 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 qualification documents/change controls related to your area.
- 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)
- Trending of LIR, events, and QARs
- 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.
Degree: University degree in a scientific discipline
- Preferably experience in a manufacturing environment
- Experience with quality investigations and release of biological products or vaccines is an advantage.
Specific training and skills
- Analytical skills
- Good communication skills, verbal and in writing, in Dutch & English
- Excellent documentation skills (technical report writing in Dutch/English)
- Good time management and prioritizations skills
- Human interactions (diplomacy, convincing, assertiveness, ...)
Anneleen De Vos
015 21 11 04