Responsibilities of the QA Release Engineer
- Assure that products manufactured and packaged on site and by Third Party Manufacturers meet Company and legal requirements.
- 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 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.
- 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
- 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.
Profile of the QA Release Engineer
EDUCATION, TRAINING AND/OR EXPERIENCE
- University degree in a scientific discipline, preferably in Pharmacy
- Analytical skills
- Excellent documentation skills (technical report writing in Dutch/English)
- Good time management and prioritizations skills
- Human interactions (diplomacy, convincing, assertiveness, …)
- Good communication skills, verbal and in written, in Dutch & English
Nice to have
- Preferably experience in a manufacturing environment or packaging environment
- Experience with quality investigations and release of biological products or vaccines
Offer for the QA Release Engineer
- Challenging projects based on your interests and skills
- Personal follow-up and clear, transparent communication both before and after commencement of employment
- Possibility to follow extra training
- Inspiring network events and legendary after work drinks
- Strong network of industry leading clients
- Expertise within IT, Engineering and Life Sciences
- A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees