QA Validation Specialist
* Requisition ID: WD163400
* Position: Full-Time Regular
* Open date: Apr 16, 2018 12:49 PM
* Functional area: Quality
* Required degrees: Not Indicated
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The QA Primary Validation Specialist is part of the QA Operations for one MPU. He/She ensures the QA oversight of the continuous validation activities for bulk production unit
*Take part in the establishment, the implementation, the follow-up and the maintenance of the continuous validation plan (CVP) of a Primary MPU
* Define the validation strategies through the change control process (eCC)
* Challenge, review and approve qualification and validation (IQ, OQ, PQ, PV) documentation and ensure they are written in accordance with the GSK Vaccines standards and procedures
* Write validation (VP, PQ, PV, VSR, PVMP) documentation according to the GSK Vaccines standards and procedures
* Support from a compliance point of view the MPU Product&Process, Production and QA Operations for validation topics. Build a strong partnership with these key stakeholders.
* Ensure adequate oversight and follow-up on the validation deviations both in terms of content (root cause and CAPA)
* Support the validation approach and decision during internal and external inspection and prepare the strategy of defense with MPU Product&Process, Production and QA Operations.
* Provides QA expertise support to new product introduction projects and related validations
* Develop and continuous improve expertise linked to the primary validation activities
Why You?Basic qualifications:
* University degree: master degree in Sciences/Engineering e.g. Pharmacist / Master in Sciences / Bio Engineer
* Minimum 5 years of experience, of which 3 in a pharmaceutical /biological production environment
* Strong knowledge of GMP.
* French speaker with written and spoken English skills
* Experience in validation activities
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.