We are looking for an energetic, open-minded and versatile individual to join a pioneering company at the forefront of synthetic and stem cell biology, manufacturing human cells for research and drug discovery purposes. The company is expanding its QA department (currently 4 people), with further growth next year, and they are looking for a QMS Specialist who can undertake a range of projects.
This is a permanent position, paying around £45,000 plus excellent benefits. For the right person, the salary could be a little higher than this too. You will be based in the company’s modern site in Cambridge, though they have a very healthy approach towards the current Covid-19 guidelines and will accommodate you working some portion of the time from home, not just in the short term.
Reporting to the Head of QA, your role will include:
- Supporting the company’s HTA licence application.
- Developing systems and establishing procedures for documenting and monitoring processes such as non-conformities, change controls, deviations, Root Cause Analysis, CAPAs, internal and external audits, supplier approval, risk assessments, continuous improvement and signature register.
- Leading change management such as non-conformities, change controls, deviations and CAPAs.
- Ensuring that QA documentation and processes are current and in line with the relevant regulatory requirements.
- Providing review, approval and QA Technical support to key business partners for the management of quality records e.g. risk assessments, continuous improvement, change controls, non-conformities, deviations, CAPAs, supplier approvals and Root Cause Analysis.
- Implementing, monitoring and providing appropriate KPIs for the QA processes, escalating any trending observed to senior management.
- Creating, revising and maintaining QA standard operating procedures (SOPs) and other documents as required.
- Acting as QA subject matter expert to support business requirements.
- Ensuring the internal audits are up to date
- Providing direct Quality team support during customer audits and regulatory inspections.
- Ensuring actions from customer audits and regulatory inspections are tracked, followed up internally and ensure responses are sent out to the customer/or regulatory bodies
- Providing direct support for quality-related customer complaint investigations and trending activities and ensure responses are sent to customers
- Providing Quality systems and process training across the business.
- Managing the archiving of business data, both paper-based and electronic.
- Managing the collation of data reporting of the Annual Product Reviews for approval.
- Writing, reviewing and approving Quality Technical Agreements.
Benefits:
In addition to a generous basic salary, the company offers the following benefits package:
- 30 days holiday
- 5% match contributory pension - after three months
- Private healthcare - with Vitality (the highest level of cover you can get) after three months
- Life assurance
- Cycle to work scheme
- Electric car scheme - coming in soon
Skills and Experience Required:
- Strong experience of Quality Assurance gained within a commercial Pharmaceutical setting, ideally in a Biologics, Cell Therapy / ATMP or Biopharmaceutical organisation, regulated to GMP and HTA standards
- Understanding of Continuous Improvement Tools e.g. LEAN, 5S, Kanban, Kaizen, RCA, VSM.
- Experience of document control and the optimisation of QMS processes, especially if electronic rather than paper-based
- QESH Management System / ISO9001 / PDCA Training preferred
- Strong proficiency in Word, Excel and PowerPoint
- Life science qualification helpful but not essential
- Excellent communication skills and ability to work with people at all levels
- Proactive, driven, 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 Cambridge, Cambridgeshire, paying around £45,000, though this could be higher depending on experience.