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.