Responsibilities of the Junior Release Engineer
- Assure that products manufactured and packaged by us or 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.
- Design the test plans for products in your area.
- Support continuous improvement of products and processes through:
- Perform 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.
This position can be requested to participate in assignments as defined by the QA Manager /QA lead.
Profile of the Junior Release Engineer
- Degree: University degree in a scientific discipline, preferably in Pharmacy
- 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, …)
- Preferably experience in a manufacturing environment or packaging environment
- Experience with quality investigations and release of biological products or vaccines is a plus
Offer for the Junior 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