Quality Assurance Advisor - Cell & Gene Therapy (Open to flexible working)
Since the structure of DNA was discovered by James Watson and Francis Crick in 1953, significant advances have been made in our understanding of diseases caused by faulty genes.
This has led scientists to ask, "If we can pinpoint a faulty gene and correct it, could we potentially find a way to treat the genetic diseases which are so devastating for patients and their families?"
Answering this question is something GSK scientists have been attempting to do in the rapidly developing field of cell and gene therapy - a groundbreaking approach to personalised medicine that involves repairing or replacing defective genes, cells or tissue using cutting edge techniques. Now we have an opportunity to join the exciting world of GSK CGT.
The opportunity is for a Quality Advisor to join the team in Stevenage, UK to provide operational support for quality activities.
- Promote a high level of GMP awareness and compliance in business partner areas and project teams
- Approve GMP documentation, including Standard Operating Procedures validation documentation, change controls and other controlled documents from business partner areas
- Write Standard Operating Procedures pertaining to Quality Assurance and business partner GMP systems
- Perform internal assessments to measure compliance with appropriate GSK policies and procedures
- Participate in investigations, such as Quality Investigations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations
- Provide input and participate in the preparation for GSK corporate and regulatory inspections
- Perform 3rd party management activities, including audit of suppliers and contract resource organisations, utilizing third party assessment procedures
- Develop and deliver GxP training to business partners
- Participate in the implementation of the Quality Management System including, provide subject matter expertise and performing relevant impact assessments, attendance at quality council, consideration of quality policies as part of control document approval
- Generate, review and approve batch and packaging record templates
- Conduct review of Completed manufacturing and or Packaging records
- Perform material release activities where relvent in the US
- Ensure that the third party assessments are available to support material release
- Generate and approve relevant release documentation
- Provide project support including pre approval audit activities.
Application closing date: 27th April 2018.
- Bachelors degree or above in a relevant scientific discipline
- Awareness and understanding of GxP (ideally GMP)
- Laboratory or scientific experience in an industrial setting.
- Previous QA or QC/Analytical experience
- Experience working with third parties
- Experience writing SOPs
- Cell and Gene therapy exposure
GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery for strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
You may apply for this position online by selecting the Apply now button.
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