CQC Manager Testing Quality Review
- Master in Analytical Chemistry, Biochemistry, or related field
- Ideally Green Belt certified
- At least 3 years of experience in pharmaceutical industry is an asset
- Experience in biochemical, biological and/or physico-chemical assay
- Experience in project management and change management
- Good Knowledge in cGMP
- Demonstrated ability to work in multi-disciplinary teams, displaying excellent interpersonal, organizational, and communication skill
- Good communication skills towards internal clients (commercial teams, product coordinators, QA, RA, ...)
- Autonomous and proactive
- Scientific and documentary rigor
- Able to manage several project simultaneously
- Able to interact with several internal clients simultaneously
- English written & spoken
- Goof Knowledge of Microsoft Office (mainly Excel and MS project)
In the team Analytical method Remediation, the manager has the accountability of the Testing Quality Review process. This process allows identification of methods at risk for the business and ensures that action plan is defined and execute according to CQC priorities.
- Lead the Testing quality review process:
oaccountable for the scoring of CQC methods,
oaccountable and responsible of report generation
- Accountable for the in use status of the project by tracking process progress, following specific KPI and reporting to the defined governance.
- Coordinate and facilitate the initial evaluation of high and medium risk methods.
- Continuous improvement of this new process and tools used for the scoring
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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