QA Manager

3 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.

Main responsibilities:

·· Management of the 3rd party Quality team, ensuring appropriate training plans to ensure their personal development and growth

· To ensure that batch reviews are completed by the team within the required timeframe for QP release

· To be the point of contact for supply chain and other QPs with respect to batch release and associated issues

· Liaise with relevant parties to communicate any issues with product supply and assist with the resolution as required

· 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

· To participate in, or lead audits of CMOs or Distribution Partners in accordance with the agreed schedule

About you

· Excellent time management, communications, decision-making, and organisation skills

· Positive mindset, ethical yet pragmatic

· Team player, able to work with remote colleagues and diverse cultures

Skills/Education

· 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

with ICH Q10 requirements

· Auditing experience

· Understanding of Good Manufacturing Practices

· 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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