Coordinator QA oversight
- Master degree: Pharmaceutical Sciences, Biology, Chemistry, Bio/Chemical Engineering or any other applicable scientific discipline.
- 3-5 years in Pharmaceutical industry, with specific experience in a quality and/or validation role and knowledge of quality systems and vaccines regulations.
- Very good knowledge of French and English.
- The QA Oversight validation coordinator must be able to:
- Understand quickly the characteristics and the mechanisms of a broad range of processes and systems including their potential impact on product quality and patient safety,
- Use a risk-based approach for problem solving and prioritization of tasks,
- Blow a quality and compliance mindset through the validation activities,
- Become a strong advocate for validation approaches and activities during internal and external audits.
- Oversight the validation SME on various subjects linked among others, to equipment sterilisation and decontamination, clean utilities validation, etc
- Support of the site during audit and inspection for various validation subjects
- Improve & align his/her expertise to current GMP requirements
- Compliance Authority of SOP, transversal CAPA / transversal risk & issues, involvement in validation deviations and voice of the site regarding validation
- Accountable for system effectiveness review of validation system with the SSM to meet GMP requirements
- Support model in complex and transversal areas linked to validation.
- Support during corporate and regulatory inspections for validation related topics.
- Review and participate in the improvement of the Global Standards, Technical Standards, to enhance compliance, standardization and simplification.
- Support the technical support and knowledge to MPU/SPU's to guarantee manufacturing and quality validation are designed and executed to deliver expected product quality, as well as robust, sustainable operations.
- Support discipline engineer of BeEM in the project for subjects linked to validation.
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.
Quality for Research & Development in partnership with R&D teams promotes quality and enables them ensuring activities of Research & Development are delivered in a compliant and sustainable way, in order to guarantee patient safety, company and regulators satisfaction, as well as successful product pipeline delivery.
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.
You may apply for this position online by selecting the Apply now button.
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