Coordinator, Operational QA for QC
- 2-5 years experience in pharmaceutical environment
- Experience in FDA/EU/WHO inspection
- Bioengineer/Pharmacist or equivalent
- Good knowledge of current Good Manufacturing Practices and Sterility Technology
- Good manufacturing and laboratories process knowledge
- Good knowledge of English (written and spoken)
- Good knowledge of FDA/EU/ICH/CDN/AUS guidelines
- Quality Control experience
- Experience in biologicals manufacturing/testing processes
- Good communication skills
- Provide QA support to QC department (Biochemistry and Physicochemistry),
- Maintain the compliance level of its QC department with regulatory and GSK standards.
- Provide QA support for the internal compliance, continuous improvement, the training, the documentation, internal – corporate and regulatory inspection
- Improve the continuous Quality and the Compliance level
- Assure regulatory inspection readiness
- Ensure QA compliance in its QC department (Biochemistry and Physicochemistry),
- Representation in meetings : intra and inter department
- QA spokesperson for the quality system department
- QA representative of quality improvement projects
Deviations and capas :
- Prepare and lead weekly deviation meetings.
- Review and challenge the QC deviations and CAPA of its QC department
- Approve QC deviation and related CAPA in accordance with procedures and timelines.
- Escalate critical deviation
- Ensure the implementation of CAPA
- Manage and follow-up of the major and transversal CAPA
- Review at least on monthly basis the quality system status of its QC department (UE, CP, changes …)
- Perform QA on the floor program in QC.
- Report any major event to its QA manager
Change and SOP:
- Review and challenge the QC change controls in accordance with procedures (matrix) and timelines.
- Approve QC changes in accordance with procedures and timelines.
- Approve QC SOP related to its QC department in accordance with procedures and timelines.
Corporate (L3) and regulatory (L4) inspection
- Give support for the L3/L4 inspection : logistic – specific topics – inspection readiness meeting
- Review the previous inspection (EIR – Commitments …).
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.
Once our pioneering treatments have been developed, they are manufactured to the highest standards and distributed across the regions that need them most. Accomplishing this as efficiently and quickly as possible can quite literally be a matter of life and death. So it's no wonder that more than 70% of our talented workforce is based within Global Industrial Operations - the essential business unit that manufactures and manages the entire vaccine supply process, from customer order to product dispatch on a global scale.
As the name suggests, it operates in a multi-national context across more than 17 sites around the world, working closely in tandem with colleagues from a variety of disciplines and professions.
The department is structured in operating units that focus on various aspects of the manufacturing and supply process. These include Industrialisation (overseeing the transfer of production from R&D to a commercial level), Supply Chain Management and Technical Services.
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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