Specialist, Product Quality Review

Job description

Details:
Job Purpose:

Ensure accurate, high quality and timely Product Quality Reviews generation in compliance with cGMP and GSK standards.

Key Responsibilities:

Review Quality performance of a family of product that is manufactured or modified at the site in order to confirm the product quality and identify product and manufacturing process improvements and hence reducing the number of Quality issues and defects.

Responsible to generate PQRs through following steps:
- Data collection
- Data analysis (identify trends, deviations recurrences, ..)
- Draft executive summary with highlights and conclusions
- Lead the consolidation meeting with production, operational QA,QA release, QC, TLCM leader
- Report highlights and conclusion to management through the appropriate escalation mecanism
- Ensure CAPA follow-up

Contribute to the continuous improvement (L1 audit) of the content and process of the Quality reviews to get PQRs used as a Quality management tool.

Be able to defend a PQR in front of inspectors.

Own PQR-related SOP, WIs.and maintain their life cycle.
Deliver training related to PQR process.

Coordinate activities of QA technicians related to data extraction and act as coach/mentor for consultants.

Our Offer:

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.

The department:

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.

Our Company:

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.

*LI-GSK

Contact information:
You may apply for this position online by selecting the Apply now button.

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Desired profile

Basic qualifications:
University degree in sciences : Pharmacist, Bio Engineer, Biologist, Chemist

Preferred qualifications:
Good knowledge of cGMP
Good knowledge of spoken and written English
At least 2 years professional experience in a regulated environment
Exposure to inspections is an asset.
Ability to work across boundaries, building strong partnership with key stakeholders from other departments (Operations, QC, TLCM, Global Quality, etc)