Quality Assurance Manager and Qualified Person

2 weeks ago

Wooburn Green Buckinghamshire, United Kingdom Ethypharm Full time

Ethypharm is a European pharmaceutical laboratory whose mission is to improve patients’ lives by providing essential drugs focusing on hospital care, central nervous system (severe pain, addiction) and internal medicine.
The role of QA Manager & Qualified Person (3rd Party) is based out of our commercial site in High Wycombe reporting to our External Operations Quality Director.

In this role you will be responsible for the management of all Quality aspects involving our CMO business, ensuring compliance with the 3rd party QMS. You will resolve day-to-day issues to maintain the quality of supply as well as providing technical input into projects such as product transfers. You will be the principle Qualified Person regarding the QP certification activities for products manufactured at multiple sites. You will manage a small team comprising 3 Quality Assurance Officers and a Quality Support Manager, working closely with supply chain, regulatory, medical info and pharmacovigilance teams.

Management of the 3rd party Quality team, ensuring appropriate training plans to ensure their personal development and growth
· Ensure compliance with the required timelines for investigations, complaints, change controls, PQRs, CAPAs, document updates, temperature excursion assessments & artwork updates impacting the 3rd party team
· To assist with the review of PQRs, temperature excursions, customer complaints, deviations, change controls and other GMP activities associated with 3rd party supply
· Excellent time management, communications, decision-making, and organisation skills
· Eligible as a Qualified Person as defined in Human Medicines Regulations 2012 (as amended)
· Good understanding and experience of Pharmaceutical Quality Management Systems in line
Understanding of ICH Q1 requirements for stability testing


At Ethypharm we recognise the value of diversity in the workplace and provide equal opportunities for all. We are always open to discussing flexible working arrangements where this meets with the needs of our business. Visit our website at to learn more about Ethypharm.

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