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 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.
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.
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