QA Release Trending & Compliance Specialist
- University or engineering degree
- Biotechnology, agronomy, chemistry or pharmacy
- At least 4 or 5 years of experience in production, validation or QA in the biopharmaceutical industry
See basic qualifications
- Acts with colleagues of the MPU Quality Assurance team and QA release team to ensure the continuous supply of vaccines in line with GSK business objectives to meet customer needs.
- Drives and leads the release QA release process in the MPU to ensure a continuous and effective release of commercial batches (intermediate or finished products produced within the Manufacturing Performance Unit) in compliance with Good Manufacturing Practices and Regulatory requirements.
- Analyses quality performance and provides trending
- Ensures the application of key businesses and GMP processes in line with the strategies, policies and standards of GSK Vaccines and fosters continuous improvement to assure a pro-active GMP compliance culture and inspection readiness of the Management Performance Unit.
- Responsible for the leadership of the QA release, trending and compliance team within the MPU.
- Represents QA in meeting related to the area of responsibility and participates to MPU Quality Council.
- Assures the QA release of batches at each production step in compliance with GMP requirements including documentation and certificate review
- Manages technical / release problems, evaluates potential impact on product quality and ensures timely escalation of issues
- Assure the management of complaints and assures the management of product recalls (Primary contact for any release related issues for GSK clients including health authorities (EMEA, FDA, AFFSAPS, PEI, SWISS MEDIC, ISP, MoHs ..) and non profit organizations (WHO, UNICEF …)
- Ensures inter-MPU back up in the area of responsibility as required
- Performs trend analysis on different quality systems to support QA Operations to further improve the systems and results
- Contributes to Inter MPU meetings to share and review trending results as to foster continuous improvement and manage risks
- Contributes to the quality strategy and the preparation of the Quality Plan for the MPU, prepares dashboards to communicate performance against objectives
- Ensures compliance of MPU processes with cGMP's and GSK Vaccines Belgium Quality Management System
- Ensures Documentation Management within the MPU is aligned with GSK Vaccines Belgium Documentation system / SOPs and performs compliance check as well as alignment with the method of production, process validation and regulatory files prior to procedure approval; ensures all MPU master production documentation is in line with validation and regulatory files prior to QA Operation approval
- Approves MPU specific GMP training packages for QA, Production and support staff within the MPU and ensures QA staff are adequately trained/certified and coach QA team through presence on the shop floor
- Approves MPU static master data
- Approves specific MPU compliance and quality risks and follows up risk register actions
- Timely escalates critical non compliance and compliance/quality risks within the MPU to management and manages these risks through the risk register process
- Ensures MPU files and Core files are aligned with current MPU processes and regulatory requirements
- Ensures all changes implemented within the MPU are aligned with GSK Vaccines Belgium change control procedures and regulatory requirements (MPU change control approvals)
- Organizes and coordinates MPU preparation for L3, L4 and RIMP inspections, applies inspection readiness program for the MPU
- Prepares internal L2 audit and L1 self inspection programs for the MPU and ensures they are performed according to schedule
- Organizes and takes the Quality Assurance responsibility for new projects (facilities – utilities – equipment – processes) in the MPU
- Ensures MPU regulatory files are adequately reviewed before submission
- Drives a continuous Quality and Compliance mindset within the MPU to ensure compliance with cGMP's and GSK Quality Management Systems as well as Regulatory Intelligence
- Maintains knowledge and experience up to date in the light of technical and scientific progress and changes in quality management
People Management & Development
- Leads, selects, trains, evaluates, coaches and motivates team towards the pursuit of excellence and attainment of Good Manufacturing Practices
- Ensures optimal staffing levels and competencies are in place and ensures the retention, engagement and development of talent within the organization
- Manages people through effective performance management and labour relations excellence
- As a leader, personally role models and develops the team toward high performance behaviors
- Engages the team to deliver the GSK Vaccines, GIO and Quality strategy
- Not applicable.
Health, Security, Environment
- Is responsible for the compliance with all applicable standards and policies
Change and continuous improvement
- Shares and integrates best practices within the GSK Quality, GSK Vaccines and wider GSK Network
- Represents quality during external regulatory audits in specific area of responsibility
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.
You may apply for this position online by selecting the Apply now button.
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