Supervisor – QA compliance Validation & Project (37874) h/f
Requisition ID: 68351
Position: Full-Time Regular
Functional area: Quality and Validation
Location: Wavre, Belgium-Wavre
Required degrees: Master's Level Degree
Basic qualifications:
Profile :
Preferred qualifications:
See basic qualifications
Details:
Our Company:
GlaxoSmithKline Biologicals (GSK Biologicals), the vaccine division of the GSK Group, is a global vaccine research, development and production company, at the cutting edge of innovation in the fight against the most deadly infections and diseases. Headquartered in Belgium, GSK Biologicals employs over 11,000 people worldwide, of which 7,000 in its three Belgian sites: Rixensart, Wavre and Gembloux. GSK Biologicals’ global production network is in the midst of becoming the largest in the entire vaccines industry; 15 production sites strategically positioned around the world manufacture, formulate, fill, pack, check and deliver over a billion doses of about 30 different vaccines.
The department
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 15 sites around the world, working closely in tandem with colleagues from a variety of disciplines and professions.
The department itself is divided into operating units that focus on various aspects of the manufacturing and supply process. These include Supply Chain Management, Global Quality Assurance, Technical Services, and Industrialisation, which oversees the transfer of production from R&D levels to a commercial scale.
Responsibilities:
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.
Contact information:
You may apply for this position online by selecting the Apply now button.
Apply..>>>
Requisition ID: 68351
Position: Full-Time Regular
Functional area: Quality and Validation
Location: Wavre, Belgium-Wavre
Required degrees: Master's Level Degree
Basic qualifications:
Profile :
- University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)
- Good interpersonal relationship skills
- Good oral and written communication skills in French & English
- Problem solving and achievement oriented
- At least 5 years of experience in Prod., Valid. or QA in a biopharmaceutical industry
Preferred qualifications:See basic qualifications
Details:
Our Company:
GlaxoSmithKline Biologicals (GSK Biologicals), the vaccine division of the GSK Group, is a global vaccine research, development and production company, at the cutting edge of innovation in the fight against the most deadly infections and diseases. Headquartered in Belgium, GSK Biologicals employs over 11,000 people worldwide, of which 7,000 in its three Belgian sites: Rixensart, Wavre and Gembloux. GSK Biologicals’ global production network is in the midst of becoming the largest in the entire vaccines industry; 15 production sites strategically positioned around the world manufacture, formulate, fill, pack, check and deliver over a billion doses of about 30 different vaccines.
The department
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 15 sites around the world, working closely in tandem with colleagues from a variety of disciplines and professions.
The department itself is divided into operating units that focus on various aspects of the manufacturing and supply process. These include Supply Chain Management, Global Quality Assurance, Technical Services, and Industrialisation, which oversees the transfer of production from R&D levels to a commercial scale.
Responsibilities:
- Ensure the compliance in all validation activities
- Approve change control (linked to project/ validation – 1 building)
- Approve the validation documentation regarding the GMP requirements and the GSKBio procedures : URB Basic design – Validation master plan
- Approbation of risk assessment
- Approve the design qualification according to the GMP requirements and the Basic design
- Ensure timely escalation to Mgt of critical issues during validation and / or project
- Review and approve the potential CAPA plan issued from deviation or inspection
- Perform internal audit (L2) of validation activities
- Contribute to external audit (L3 corporate/L4 Belgium …) : before – during - after
- Ensure implementation of validation related commitments towards internal/external inspections
- Review and approve the system periodic review
- Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process
- Attend the BU Quality council and Risk register meeting
- Provide a compliance expertise in all BU projects
- Ensure QA oversight of GTS Facility project from URS up to SAT
- Ensure the compliance in the Projects
- Attend all project meetings as QA expert
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.
Contact information:
You may apply for this position online by selecting the Apply now button.
Apply..>>>
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