A pioneering company at the centre of the Cell & Gene Therapy sector are seeking a QA Specialist in Documentation, to join their Quality Department which is based on site in a vaccine manufacturing facility in Essex.
On offer is a competitive salary and benefits package which includes a bonus, contributed pension and strong career progression opportunities.
You will join a pioneering company who collaborate with industry and academia to ensure life-changing vaccine therapies reach patients. They offer cutting edge capabilities to take products to clinical trials through the application of their process development, manufacturing, and analytical science. As an organisation they offer excellent career development through their L&D programme, not only giving you the skills to advance your career but creating opportunities as the organisation brings in more collaborator partners and continues to expand.
The Quality Assurance Specialist - Documentation will provide the required support to team members to ensure the management of all GMP/GDP related documentation.
This role will also ensure that facility, via proactive engagement, meets the standards and expectations of all key stakeholders. The role shall be responsible for supporting the maintenance and continued development of the Quality Management System and monitoring and reporting on the operation of the QMS against agreed key performance indicators.
Assist the Quality Assurance Lead in their capacity as site Document Control Lead, conducting audits to ensure regulatory and Company requirements are met.
Issuance of new documentation, retrieval and archiving of superseded documentation.
Design, continual improvement, and maintenance of site documentation systems.
Skills & Experience:
- Strong QA experience in working with GMP quality systems in a Phase III or commercial pharmaceutical facility, manufacturing biologicals, vaccines, or cell & gene therapies.
- A proactive nature, with a real interest in progressing Quality in line with latest MHRA guidelines.
- Experience of working in a smaller or start-up organisation, with a pragmatic attitude and great problem-solving skills.
- Ability to work well under pressure, to work independently and to be able to take the initiative when completing tasks.
- Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives and to respond to a wide range of customer and management needs.
- BSc, MSc or similar in a life science discipline.