Job Description
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.