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description de la société
For a major player in the global pharmaceutical industry, we are looking for a QA Release Engineer.
description de la fonction
Randstad’s mission is to shape the world of work by being a world leader in matching supply and demand in the labor market and in HR services. Randstad Professionals is part of the Randstad Group and creates opportunities for highly qualified and skilled professionals to work on successive projects on customers’ site.
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: 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. 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.
EDUCATION, TRAINING AND/OR EXPERIENCE
Degree: University degree in a scientific discipline, preferably in Pharmacy Specific training and skills required 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, ...)
Nice to have Preferably experience in a manufacturing environment or packaging environment Experience with quality investigations and release of biological products or vaccines
You are flexible and you will receive a lot in return. You will get an attractive salary package with extra benefits: - group insurance, - hospitalization, - meal vouchers, - representation costs - training, ...