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Operational Quality Manager - Aseptic Services

SRG | Luton | findajob.dwp.gov.uk |
Operational QA Manager requited for a sterile manufacturing company based in Luton

Skills and Experience
 •  Master's Degree in pharmacy.
 •  UK registered pharmacist.
 •  Minimum of 6 months experience in pharmaceutical industry.
 •  GMP knowledge and experience preferred.
 •  Strong literacy, written and numerical skills essential.
 •  Good IT skills.
 •  A keen team player who is supportive of work colleagues
 •  Enthusiastic in their approach to workload and capable of working towards KPI's
 •  An excellent communicator who is honest and respectful

In this role you will:

 •  Ensuring that all QPL licences and authorities are maintained and acting as the key contact for the MHRA and Home Office.
 •  Leading and closing any audits performed by the above authorities, or per customer/client.
 •  Monitoring and investigating trends in quality KPI's, namely fails, rework and complaints and report to the Board.
 •  Leading a culture of continuous quality improvement by constant monitoring and review of the Quality Management System.
 •  Promoting and educating colleagues in GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices).
 •  Acting as Quality authorisation, signing off in conjunction with the Quality Director.
 •  Developing a strategy for the Quality Department with the Executive Directors to ensure continuous regulatory compliance whilst supporting business development and meeting board objectives.
 •  Providing Aseptic Quality input into the Management Review; ensuring outstanding issues are actioned and resolved, reporting to the Board if necessary.
 •  Providing quality information to other departments as required for new customer business, product, and service tenders.
 •  Leading, developing, and promoting the change management system within QPL including any validation requirements arising.
 •  Being able to act as a principal signatory for release of aseptically manufactured products.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.