GlaxoSmithKline Biologicals (GSK Biologicals) is one of the world's leading vaccine manufacturers. The company is located in Rixensart (Belgium) and is the centre of all GlaxoSmithKline's activities in the field of vaccine research, development and production. GSK Biologicals employs over 5 000 people in Belgium (over 8 000 worldwide), of whom more than 1 500 are passionate scientists devoted to discovering innovative vaccines and developing cost-effective and convenient combination products that contribute to the health and well-being of billions of people, in every generation around the world.
Support the Sites and the CMO in order to ensure RA and GMP compliance on GSKBio sites :
Perform visit on site in order to coach the Site/CMO QA regarding new QA processes and GSOP
Establish a network between the Site/CMO QA and the experts in order to facilitate processes implementation
Establish a site support coordination plan involving all GQA teams
Establish a Site/CMO report after each visit
Perform, monthly, one report per site based on site document review
Escalate 1x/month the conclusions of the previous report to the GQA Mgment team and the Regional VP in order to prepare the Bio QC
VMP approval
VMP input for inter-sites transfer
Coach and facilitate the implementation of new site quality system
Coach the site to succeed the audit regarding the GO/NOGO for production
Facilitate and support the RA site inspections and help sites to define corrective actions to observations
GSOP and New processes
Representative of GQA in the establishment or the review of some GSOP regarding QA processes
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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.
Thank you for taking the time and effort to apply for this role. Please note that we will only contact you again if you are invited to interview. 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
Pharmacist, Chemist or Biochemist
Experience: 10 years in Pharmaceutical Company- aseptic products
QA experience with excellence knowledge of GMP's
Willing to travel
GlaxoSmithKline Biologicals