Release Engineer

Job Title : Release Engineer
Job Location : Puurs, Belgium
Job Duration : Contract


EDUCATION, TRAINING AND/OR EXPERIENCE
1 Degree: University degree in a scientific discipline, preferably in Pharmacy
2 Specific training and skills required
o Analytical skills
o Good communication skills, verbal and in written, in Dutch & English
o Excellent documentation skills (technical report writing in Dutch/English)
o Good time management and prioritizations skills
o Human interactions (diplomacy, convincing, assertiveness, ...)
3 Nice to have
o Preferably experience in a manufacturing environment or packaging environment
o Experience with quality investigations and release of biological products or vaccines

PRINCIPAL ACCOUNTABILITIES
• 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.
• 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:
o Quality deviation investigation (events/QAR's)
o Trending of LIR, events and QARs
o Participation in operations, product and system teams and Daily Operations Review meetings
• Contribute to timely supply of products.
• Release authority:
o Product batches that meet Company and legal requirements (PQS, GMP etc).
o 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.
This position can be requested to participate in assignments as defined by the QA Manager /QA lead.