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I am currently looking to recruit an Operational Quality Manager, to work for one of the UK's leading pharmaceutical manufacturers. With an exciting expansion in Aseptic Services, the client has just opened a state-of-the-art aseptic manufacturing facility in Luton.
Your duties will include, but not be limited to:
Lead and Inspire: Build and manage a high-performing, collaborative quality team that embodies our Group's values.
Drive Excellence: Develop, implement, and monitor the microbiology testing and environmental monitoring program.
Ensure Quality: Oversee a team of batch-releasing officers to maintain the highest standards for aseptically compounded medicines.
Monitor Trends: Investigate trends in quality KPIs, including fails, rework, and complaints, and report findings to management.
Promote Best Practices: Educate colleagues on GMP (Good Manufacturing Practices) and ensure compliance.
Support Inspections: Assist the Head of Quality in leading and closing MHRA and Home Office inspections.
Strategize for Success: Work with Executive Directors to develop a strategy for the Quality Department, ensuring ongoing regulatory compliance and alignment with business development goals.
Collaborate and Communicate: Provide quality input for management reviews, address outstanding issues, and support other departments with quality information for new business, product, and service tenders.
We're looking for an experienced, forward-thinking individual who meets the following criteria:
Proven experience in a similar role, ideally in aseptic manufacturing.
A degree in a life sciences discipline (e.g., pharmacy, microbiology, chemistry).
At least 5 years of relevant GMP experience within a licensed facility or under a section 10 exemption.
Comprehensive, up-to-date knowledge of GMP practices.
A self-starter with a demonstrated ability to work autonomously and make decisions confidently.
Strong interpersonal skills with the ability to engage with colleagues at all levels.
High computer literacy, particularly with Microsoft Office software.
A recognised management qualification is desirable but not essential.
In addition to a competitive salary, you will also be entitled to other benefits including flexible shift patterns, pension, free food and drink at work, Cycle to work scheme, EV Scheme etc.
