Coordinateur QA Transversal Utilities & Operations
- At least 3-5 years of experience as QA or technical expert in a pharmaceutical/bio/medical device environment or equivalent
- Technical or Scientific diploma
- Very good knowledge of cGMP
- Fluent in spoken and written English
- Good knowledge of industrial maintenance practices
- The job purpose is to be the Technical Quality support regarding activities performed by the team "Transversal Utilities & Operations" Belgium Engineering & Maintenance.
- Be the technical specialist providing quality support to the activities of the team "Transversal Utilities & Operations" (Power Plants, Electricity and Pest Control).
- Act as an expert regarding: knowledge of the QMS standards related to the area of expertise, ensure all requirements of the standards are cascaded in SOP's.
- Proactively identify conformity or quality issues and manage potential risks through the risk management process in place. Promote Risk Based approach when accepted. Ensure timely escalation to management of critical issues upon detection.
- Ensure that deviations, CAPA, change controls are followed in a timely manner and respect the procedures.
- Ensure a shop floor presence to maintain quality in a continuous improvement approach.
- Provide support, monitoring and approval regarding activities of the maintenance team "Transversal Utilities & Operations."
- Ensure Quality Oversight and support the activities of "Transversal Utilities & Operations."
- Perform self-inspections activities (L1).
- Ensure administrative activities regarding internal or external inspections (preparation, ensuring action plans ...).
- Provide transversal support to MPU when needed in terms of quality of maintenance processes.
- Be an active player in the deployment of the implementation of the quality program within the department "Transversal Utilities & Operations."
- Represent QA in all meetings related to the area of responsibility (Tier/staff meetings, deviations, CAPA, change controls, projects follow-up meetings …).
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.
Global Quality Departments is responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.
The QA Belgium departments manage all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. The QA Belgium department is also responsible for the release of final products made in Belgium and abroad.
GSK is one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Vaccines is one of the world's leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world's countries.
For further information, please visit www.gsk.com.
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