For a client in the region of Puurs/Bornem, we are looking for a motivated and enthusiastic starter!
- Are you in the possession of a scientific master's degree (preferably pharmacy)?
- Do you have a first experience in the laboratory?
Then you are the Release Engineer we are looking for!
This department is accountable for releasing products, either locally produced or produced by a Third Party Manufacturer, to the market, in accordance with Company and legal requirements (PQS, GMP etc).
This position is accountable for performing and documentation of all necessary investigations related to the Laboratory (Chemical and Microbiological) to support assessment of the product being acceptable and make proposals for continuous improvement of products and processes.
This position is the primary contact for the Chemical and Microbiological Laboratory in case of quality deviations.
This position reports to the QA Lead within the Quality team responsible for the Laboratory (Chemical and Microbiological).
- Evaluate incidents that occur in the Laboratory (Chemical and Microbiological) and prepare recommendations to the QA Manager/QA lead.
- Review and approve Laboratory investigation reports (LIR) related to Out-of-Specification results, Questionable results and prepare recommendations to the QA Manager/QA lead.
- Evaluate Laboratory investigations, corrective and preventive actions and verify effectiveness in order to prevent recurring deviations.
- Coordinate cross functional investigations in case of complex investigations and work closely with the Laboratory (Chemical and Microbiological) and supporting departments.
- Assure that products manufactured and packaged in Puurs and by Third Party Manufacturers to the Puurs plant meet Company and legal requirements.
- Assure that products purchased and used in the Puurs plant meet Company and legal requirements.
- Operate and maintain the Quality Assurance systems.
- Approve qualification documents related to the Laboratory (Chemical and Microbiological).
- Approve master documents and SOP's.
- Prepare Quality Performance Review.
- 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.
- Degree: University degree in a scientific discipline, preferably in Pharmacy
- Preferably experience in the laboratory.
- 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 written, 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