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Operational Quality Manager - Aseptic Services

Job details
Posting date: 24 April 2024
Salary: £50,000.00 per year
Hours: Full time
Closing date: 24 May 2024
Location: Luton, Bedfordshire, LU1 1UU
Company: SRG
Job type: Permanent
Job reference: BBBH139989_1713953608

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Summary

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.

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