At a Glance
- Tasks: Certify sterile products and ensure compliance with EU GMP regulations.
- Company: Forward-thinking pharmaceutical company based in Sheffield.
- Benefits: Competitive salary and the chance to make a real impact in patient safety.
- Other info: Full-time, site-based role with opportunities for professional growth.
- Why this job: Join a team dedicated to quality and regulatory excellence in healthcare.
- Qualifications: Must be a Qualified Person with experience in certifying sterile products.
The predicted salary is between 45000 - 55000 £ per year.
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.
- Base pay range
- Direct message the job poster from Assure Bio
- 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.
This is a fully site-based role and remote or hybrid working is not available.
- Seniority level
- Mid-Senior level
- Employment type
- Full-time
- Job function
- Quality Assurance
- Industries
- Pharmaceutical Manufacturing
- #J-18808-Ljbffr
Qualified Person (QP) in Sheffield employer: AssureBio
AssureBio is an exceptional employer, offering a dynamic work environment where innovation and regulatory excellence are at the forefront. With a strong commitment to employee development, you will have access to numerous growth opportunities while working alongside a dedicated team in a state-of-the-art facility. Located in the UK, our culture promotes collaboration and continuous improvement, making it a rewarding place to advance your career in the pharmaceutical industry.
