Superviseur QC V Biochimie
- Engineer/University degree with experience in industry or PhD in Biology/Biochemistry/Biotechnology or equivalent.
- Proven experience (theoretical and practical) of ELISA assays, in vivo potency assays, SDS-PAGE, WB, HPSEC and rate nephelometry
- Experience in pharmaceutical industry
- Familiar with GMP
Fluent in French, good English (written & spoken)
- Good communication skills towards team and clients
- Autonomous and proactive
- Able to manage several projects simultaneously
- Able to critically review analytical data
- Scientific and documentary rigor
- The Biochemical assays Validation team is responsible for the validation of assays in the context of New Product development (PhIII), validation lifecycle and method remediation.
- The team is composed of about 20 lab technicians and 6 executives and benefits from the support of 7 external executives.
- Beyon method validation, the team participates to the definition of control strategy on New Products and to assay remediation strategy.
- The team has strong interactions with analytical research and development, commercial release teams and quality assurance and provides support to regulatory affairs and project teams.
- Performs assay validation: definition of validation strategy (according to internal and external guidance), writing of validation protocols and reports, deployment of validation studies in the lab. For methods relative to new products and commercial products.
- Ensures testing of PhIII batches and stability studies.
- Ensures that quality systems are in place in the laboratory: raw data supervision, deviation management, trending analysis,…
- Participates in the definition of control strategy on New Products
- Provides support to regulatory affairs for file writing on New Products and variations on commercial products.
- Able to interact with Quality Assurance, statisticians, Regulatory Affairs, Production.
- Participates in regulatory inspections
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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