Operational Quality Manager - Aseptic Services

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 respectfulIn 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