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  • Location: Braintree, Essex, England
  • Salary: Highly competitive salary and excellent benefits package on offer
  • Job Type:Permanent

Posted 17 days ago

  • Sector: Quality
  • Contact: Steve Twinley
  • Contact Email: steve.twinley@nextphaserecruitment.com
  • Contact Phone: 01403 216216
  • Start Date: 2021-07-14
  • Job Ref: V-46942

Do you have strong QA experience gained in a GMP-regulated Pharmaceutical or Biologics environment? A new role has been created for a QA Specialist, to focus on batch record review, as well as associated deviations and change controls. You will join a world-leading vaccine organisation in Braintree, Essex, which is going through significant growth.
 
This is a permanent position, paying an excellent salary and benefits (to be discussed on application). In time, you will ideally work full-time in Braintree, though for the first few months you may work a mix of site- and home-based days as we come out of Covid restrictions.
 
We are looking for an energetic, open-minded and versatile individual to join a pioneering company at the forefront of vaccine production. Regulated to strict GMP guidelines, the company has created this role as part of a much larger site expansion project (including building new clean rooms and building new fermenters). This will be a perfect opportunity for you to use your range of QA skills and be part of something genuinely exciting, especially given how well respected the company is.
 
The Role:
 
You will support the QA team in the management, review and approval of all batch records and associated GMP/GDP related documentation. Working with a brand-new electronic QMS, you will:
 
This will include managing the issuing, storage, archiving and access of a paper documentation system, generating system performance metrics and acting as “doc admin” in the electronic Quality Management System. You will:
 
  • Take a leading role in the implementation and establishment of suitable governance processes to assure the manufacture of product conforming to GMP confirmed by the batch manufacturing documentation
  • Assist the Quality Assurance Batch Review team with the completion of batch review and approval processes to accepted timelines
  • Drive improvements / changes within operations aimed at ensuring that all documentation submitted to Quality is in an approvable condition
  • Manage the Batch Review priority list – escalating any identified issues or delays to senior members of the Quality and Operations teams
  • Ensure procedures are implemented site-wide to ensure product is manufactured within the parameters set out in the QMS
  • Collate quality metrics for analysis
  • Oversee, control and manage the site procedures for control of all forms of documentation
  • Assist the Quality Assurance Lead – Document Control and Quality Standards in their capacity as site Data Integrity lead, conducting audits
 
Skills and Experience Required:
 
  • Good qualification (ideally BSc / MSc or similar) in a Scientific discipline
  • Experience of Quality Assurance gained within a commercial setting, ideally in a Biologics, Biotech, Cell Therapy / ATMP or Biopharmaceutical organisation, regulated to GMP standards
  • Strong understanding of the use of a Quality Management System – ideally an electronic one such as Trackwise or Q-Pulse
  • Excellent communication skills and ability to work with people at all levels
  • Great attention to detail and ability to maintain and manage a range of documentation
  • Pragmatic, open-minded, emotionally intelligent, positive and respectful approach to your work
 
Full details will be provided on application. This is a permanent role in Braintree, Essex.