QA Operations Specialist
* Requisition ID: WD163398
* Position: Full-Time Regular
* Open date: Apr 16, 2018 12:54 PM
* Functional area: Quality
* Required degrees: Not Indicated
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As QA Operations Specialist you are responsible to assure quality management is implemented following the latest requirements in a bulk production unit
* Masters the key QA activities and KPId related to production activities in his/her area of responsibility
* Ensures batches of the intermediate product related to the area of responsibility are released in a timely manner
* Ensures deviations, complaints, change controls, OOS investigation are reviewed and handled in a timely manner
* Represents QA (decision responsibility) in all meetings related
to the area of responsibility (staff meetings, deviation, CAPA, Change Controls follow-up meetings)
* Ensures critical topics are adequately escalated to higher management
* Acts as QMS subject matter expert (SME) (= knowledgeable of the
QMS standard related to the area of expertise, ensure all requirements
of the standards are cascaded in SOP's, accountable for gap analysis and
related action plans)
* Is the preferred front line spokesperson during inspection for the subject of expertise as well as for all operational aspects belonging to the area of responsibility
* Understands technical/production complex problems and evaluates potential impact on product quality
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
* Knowledge of GMP regulated environment
* Leadership , decision making,critical thinking and analyse of issues, impact and influence, innovative thinking, engage people, achieving excellence
* Very good knowledge of English
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.