Do you have a passion for developing efficient, robust Quality Management Systems? Do you have a background within Pharmaceutical or Biologics environments, regulated to GMP (and ideally HTA) standards? If so, this is a genuinely unique opportunity for an ambitious, positive-minded individual, to join a fast-growing cell therapy organisation in Cambridge, which is just about to implement a brand-new electronic QMS.
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 from 2 to 5 people, with further growth next year, and they are looking for a QMS Specialist who can undertake a range of exciting 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:
Develop systems and establish 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.
Lead change management such as non-conformities, change controls, deviations and CAPAs.
Ensure that QA documentation and processes are current and in line with the relevant regulatory requirements.
Provide 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.
Implement, monitor and provide appropriate KPIs for the QA processes, escalate any trending observed to senior management.
Create, revise and maintain QA standard operating procedures (SOPs) and other documents as required.
Act as QA subject matter expert to support business requirements.
Ensure the internal audits are up to date
Provide direct Quality team support during customer audits and regulatory inspections.
Ensure actions from customer audits and regulatory inspections are tracked, followed up internally and ensure responses are sent out to the customer/or regulatory bodies
Provide direct support for quality-related customer complaint investigations and trending activities and ensure responses are sent to customers
Provide Quality systems and process training across the business.
Manage the archiving of business data, both paper-based and electronic.
Manage the collation of data reporting of the Annual Product Reviews for approval.
Write, review and approve Quality Technical Agreements
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
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 (i.e. closer to £50k) depending on experience