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Quality assurance specialist

Hays Life Sciences
Quality assurance specialist
Posted: 21 April
Offer description

Your new company
You will be joining a long‑established pharmaceutical organisation with nearly a century of heritage, operating across the globe. The company develops proprietary medicines and also runs a global manufacturing division producing active pharmaceutical ingredients, supporting millions of patients worldwide. You'll be part of a business focused on high‑need therapeutic areas including neuroscience, oncology, ophthalmology, dermatology, metabolic conditions and rare diseases, underpinned by strong values centred around transparency, accountability and patient‑centricity. The organisation has undergone a strategic shift toward specialised medicines in recent years, divesting its generics arm and expanding through targeted acquisitions, supported by significant, ongoing investment in R&D and advanced manufacturing capabilities.

Your new role

Product Release & Compliance: Ensure compliance with Good Manufacturing Practices (GMPs) and Good Distribution Practices (GDPs) by managing/coordinating the release processes (QP/RP/RPi). Verify documentation completeness and ensure adherence to quality standards.
Quality Systems & Continuous Improvement: Maintain and enhance Quality Systems and processes (including Change Control, Deviations, Complaints, Product Quality Review (PQR), Recalls, and Returns), ensuring regulatory alignment. Monitor quality metrics, establish KPIs, and implement action plans for continuous improvement and system effectiveness.
Regulatory Compliance & Audits: Act as a liaison with Health Authorities, ensuring regulatory compliance and timely reporting of quality incidents. Oversee Contract Manufacturing Organisations (CMOs). Lead and coordinate quality audits from authorities and external stakeholders.
Risk Management & Documentation: Promote technical knowledge and quality risk assessment within the Organisation. Participate in new product development projects, ensuring GMP/GDP compliance. Review and approve Change Control, SOPs, and Work Instructions (WIs) to support operational excellence.
CAPAs & Reporting: Implement and monitor Corrective and Preventive Actions (CAPAs) and assigned tasks in TrackWise, ensuring timely resolution. Prepare and submit monthly KPI reports to the Global Compliance Directorate to track performance and drive improvements.
What you'll need to succeed
You will bring previous experience within a regulated environment, strong attention to detail, and a solid understanding of quality principles. Excellent communication skills, the ability to work cross‑functionally, and a proactive approach to problem solving will help you thrive in this position.
Must have full right to work in the UK. No sponsorship provided.

What you'll get in return
You'll join a supportive team environment with opportunities for growth, competitive benefits, and the chance to contribute to meaningful work within an industry that makes a real impact.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up‑to‑date copy of your CV, or call us to discuss further

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