Operational QA Specialist, Visual Inspection
Develops, assures and maintains the quality of the product and processes for Filling and visual inspection
- Standard procedures
- Quality audits/review
- Key Performance Indicators (KPIs)
• Masters the key QA activities related to production and validation, project 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, maintenance and calibration plans are reviewed and handled in a timely manner
• Supervises a team of technicians if applicable, distributes their work and is responsible for their training and development plan
• Represents QA (decision responsibility) in all meetings related to the area of responsibility (staff meetings, deviation, CAPA, RPC follow-up meetings, ICG project, ...)
• 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
• Leads local and/or transversal improvement projects to ensure the compliance level is maintained in line with cGMP and GSK standard requirements
• Understands technical/production complex problems and evaluates potential impact on product quality
• Assesses quality review files and draws adequate conclusions
• Provides QA expertise support to new product introduction projects and related validations
• Scientific university degree (Pharmacist, Engineer or equivalent)
• Very good knowledge of English
• Knowledge of GMP regulated environment
• Minimum 5 years of experience in a Pharmaceutical/Bio/Medical device environment or equivalent
See Basic Qualifications
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 - 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.
At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
If you require a reasonable adjustment to the application/selection process to enable you to demonstrate your ability to perform the job requirements you will have the opportunity to let us know what specific assistance you require. This will help us to make suitable arrangements to support you throughout our selection process.
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.
You may apply for this position online by selecting the Apply now button.
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