Computer Compliance Senior Specialist
- University Degree in Science (Chemistry, Biology, biochemistry, Bioengineer or Pharmacy)
- Specialisation in Vaccines – Life science – BioInformatics – Computer Engineering – Regulatory Requirements in Pharmaceutical environment
- To have a good understanding of the processes supported by the computerized, automated and analytical tools
- At least 7-10 years' experience in validation: fundamental steps of the V Cycle, GAMP 5, Validation methodologies and related documentation. Good knowledge of international standards (CFR and Eudralex), GXP expectations. Good knowledge of inspection process. Previous participations to regulatory inspections.
- Knowledge of software and hardware development.
- Knowledge of project management and risk management principles and tools.
- Experience on Spreadsheets validation (Excel, SofMaxPro,…).
- Knowledge of IT Environment.
- Knowledge of compliance rules and recommendations for CSV area (21 CFR part 11, GAMP) and for Business in pharmaceutical industries (GLP, GCP, GMP).
- Knowledge of R&D environment is mandatory.
- Previous experience in GSK (R&D or Manufacturing) is a great asset.
- Fluent in spoken and written English both scientifically/technically as well as conversational.
- Good communication skills are expected as well as a spirit of initiative.
- Strong presentation skills. Ability to prepare training content and deliver training session.
- Customer focused.
- Ability to manage networks and build relationships transversally across the Vaccines network.
- Flexible thinking.
- Strong knowledge and expertise of quality systems, specially of key/ core, such as, Deviation/Investigation, Documentation Management, Training, Change Control, CAPA, Product Disposition, Validation).
- Ability to adapt, work under uncertainty and accommodate flexible work demands.
- Ability to withstand pressure.
- Self-motivated; Sense of urgency.
- Travel: 5% - 10%
- Responsible for ensuring the quality oversight on computerized and automated / analytical systems used in Vaccines R&D and by Vaccines external partners
- Be involved in the development of Computer Validation and ERES management strategies in R&D (three R&D Centers) to align with GSK requirements (electronic records and signature use, audit trail coverage, records archiving)
- Be directly involved in a Community of Practice on Computer Compliance which targets all GSK Vx R&D sites.
- Oversee that the R&D data generated electronically (or hybrid process) is obtained, used, back-ups performed and archived in accordance with GXP and GSP (Good Scientific Practices), corporate and international regulations
- Monitor the accuracy and quality of the data used in drug discovery
- Ensure in the quality assessments (e.g. audits and inspections such as L2, L3, L4) that the internal and external audit processes and tools are applied
- Be involved in the development of SOP's for quality standards in collaboration with other departments (GIO/Clinical/IT) based on global Quality Assurance and/or Corporate Policies
- Approve when applicable any procedures, validation protocols, validation results and conclusions as par QS
- Make the final approval of the validation processes and associated documentation
- Manage technical complex problems, evaluate potential impacts on quality and ensure that the critical topics are adequately and timely escalated to management
- Provide QA expertise and support to related customers and teams
- Interact with Corporate colleagues and teams to discuss about quality aspects in global R&D
- Support standardization of processes and approaches for different systems and for different sites, harmonize practices in the team and between other QA teams
- Oversee QA requirements for IT quality systems with potential GxP impact are met
- Oversee QA requirements for automatic and analytical systems are covered (procedure approval, validation methodology)
- Ensure that the GxP requirements for critical R&D systems are covered and approved. Support GxP decisions/strategies during validation projects
- Review and approve deviations and change control for critical systems
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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