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Qualified person

Sheffield
AssureBio
£60,000 - £80,000 a year
Posted: 21 September
Offer description

Are you a Qualified Person ready to make a real impact in sterile manufacturing?

Whether you're newly qualified or bring years of experience, this is a fantastic opportunity to join a forward-thinking pharmaceutical company based in Sheffield.

You'll play a vital role in ensuring the safety, quality, and compliance of sterile medicinal products, supporting a business that places patient safety and regulatory excellence at the heart of its operations.

What You'll Be Doing

* Certifying batches of sterile products in line with EU GMP and regulatory requirements.
* Reviewing batch documentation, analytical results, and deviation reports to ensure product integrity.
* Leading and supporting investigations into quality issues and implementing effective CAPAs.
* Participating in internal and external audits, contributing to the continuous improvement of the Quality Management System.
* Providing expert advice to cross-functional teams on quality standards and compliance expectations.

Who We're Looking For

* A Qualified Person eligible under UK regulations, with full QP status.
* Experience certifying sterile products is essential – this could come from clinical, commercial, or aseptic manufacturing environments.
* A solid background in pharmaceutical QA and manufacturing, ideally within sterile operations.
* Proven experience working with Quality Management Systems and regulatory frameworks.
* A relevant scientific degree (Pharmacy, Chemistry, Biology, or similar).
* Strong communication, problem-solving, and decision-making skills.

Whether you're stepping into your first QP role or bringing years of insight, you'll be supported by a collaborative, quality-driven team in a hands-on environment.

Please note: This is a
fully site-based
role and remote or hybrid working is not available.

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