QC Product Coordinator
- A university certificate with scientitific orientation (Bio engineer, Biology, Biotechnology, Pharmacology,…) or equivalent experience.
- 2 years experience in QC or analytical development
- Practical and theoretical knowledge in the domain of laboratory activity (e.g. Biochemistry, Chemistry, Virology,…)
- Good knowledge of English (oral and written)
- Knowledge of regulatory matters and Good Manufacturing Practices (GMP).
- Analytical and critical mind, global and pragmatic approach, problem solving.
- Good impact and influence skills as well as networking skills to efficiently work within QC matrix organization and other GSK Vaccine departments.
- Leadership skills to foster teamworks
- Good technical writing skills.
- The incumbent will provide support to a QC Product manager in the management of several GSK Vaccines analytical lifecycle product from late clinical phase to and including the commercial phase, bringing the analytical and stability expertise to multi-disciplinary Technical teams and Governance bodies. He/she is accountable for the writing of stability protocols and reports, the analytical and stability sections of the product quality review, and critical deviations, integrating all analytical aspect of continuous improvement (Vigilance, Technology, and Regulatory Requirement) and supply demands (challenge and adjust analytical development & strategy to support their right application in commercial phase).
- Will provide support to a QC Product manager for the global QC product coordination for several products from late clinical phase to and including the commercial phase bringing the QC voice and analytical expertise to multi-disciplinary Technical teams and Governance bodies.
- Is accountable for the coordination of the timely writing of the analytical and stability section of the product quality review and the coordination of the implementation of identified improvements (CAPA) for the products under his/her responsibility.
- Is accountable for the coordination of the timely writing and approval (before submission) of the QC sections of regulatory files, variations and Question and Answer reports for the products under his/her responsibility. Is accountable for providing the intermediate and final QA approved stability reports within the timelines agreed with RA in the frame of variations and commitments.
- Approve and coordinate the QC tasks in the frame of transversal Change control identified within Technical Team,
- Establish the testing and stability strategies for the products under his/her responsibility. Is accountable for creating and modifying accordingly the vaccines monographs and stability plans.
- Is accountable for performing the adequate statistical trending of release and stability results in order to confirm shelf-life and specifications.
- Bring vaccine analytical expertise within the technical teams, integrating all analytical and stability aspects (Vigilance, Technology, and Regulatory Requirement).
- Is accountable for the coordination of QC critical deviations. Ensure that all the technical activities related to the investigation of significant analytical and quality issues are conducted to guarantee the continuity of supply and are in accordance with the current regulations.
- Identify risks on technical feasibility and supply, timing and resources constraints and seek a remediation plan for identified risks and escalade any analytical technical and/or supply issues to the relevant body (QC management, project team, escalation, performance tower…) for one product category. Consolidate a monthly progress status shared with the key stakeholders.
- Coordinate the alignment of QC labs deliverable link to testing of lifecycle product improvement projects in line with Global supply chain objectives in terms of quality, time and cost. Negotiate with the laboratory heads the resources allocation and development activities to achieve the target .Collect & Challenge demands for Demand & Planning (QC planning and prioritization tool) purposes for one product category.
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.
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