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.
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.