Skill: production , cgmp , sop , root cause; Exp: 0-3 years; QA Release Engineer Role Description The role of QA Release Engineer is situated within the QA Operations team which is responsible for Quality Assurance of the operational activities related to the production of aseptic products at the Pfizer site in Puurs. As QA Release Engineer you are the primary contact for the Production department in case of quality deviations. In addition, this position will perform and document all necessary investigations to support assessment of the product being acceptable in accordance with cGMP and Company and Legal requirements and make proposals for continuous improvement of products and processes. This position is the primary contact for production in case of quality deviations. This position reports to the QA Lead within the Quality Operations team. Main Responsibilities You assure that products manufactured and packaged in Puurs meet cGMP and Company and Legal requirements. You investigate batches not meeting specifications and prepare recommendations to the QA Manager / QA Lead. You coordinate cross functional investigations in case of complex root causes and work closely with Production and supporting departments. You evaluate root cause analyses, corrective and preventive actions and verify effectiveness in order to prevent recurring deviations. You evaluate incidents that occur in the facility of your area and prepare recommendations to the QA Manager / QA lead. You release pharmaceutical products manufactured in Puurs You operate and maintain the Quality Assurance systems. You approve SOP’s. You prepare Annual Product Reviews and Quality Performance Review. You support continuous improvement of products and processes through quality investigations (deviations) trending of deviations participation in daily operation review meetings, operations and system teams You contribute to timely supply of products. You can be requested to participate in assignments as defined by the QA Manager / QA Lead. You release batches that meet Company and Legal requirements and in alignment with a Global Quality Network. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Function: Production / Maintenance / Service Engg. / Manufacturing / Packaging