Qualified Person; QP

Overview

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.

Direct message the job poster from Assure Bio

• 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.

• 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.

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

Mid-Senior level

Full-time

Quality Assurance

Pharmaceutical Manufacturing