Job Title: Quality Operations Associate
Employment Type: Permanent, full-time
Location: Hertfordshire, UK – On-site
Role Purpose
An opportunity to join a medium-sized pharmaceutical business that specialises in Oncology and Neurology Medicines. This role within a GMP environment and will take on the day-to-day QA activities.
The Quality Operations Associate supports Quality Systems and Quality Assurance activities across pharmaceutical manufacturing, packaging, testing, storage and distribution. The role ensures ongoing compliance with GMP, GDP, internal Quality Systems and industry standards, while supporting the effective operation and continuous improvement of the Quality Management System (QMS).
Key Responsibilities
- Support the operation and maintenance of the Quality Management System, including Change Control, Deviations, CAPAs, Risk Management, Documentation, Training and Supplier Management
- Support Product Quality Reviews (PQRs) and Quality Metrics reporting
- Assist in the generation, review and maintenance of Quality Agreements
- Support supplier approval activities and maintenance of the Approved Supplier List
- Act as a Quality point of contact for operational departments and support the creation and progression of quality records in the eQMS
- Review and approve batch documentation, including packaging, bulk manufacture and intermediate products
- Support the approval and maintenance of Master Batch Records, SAP material data and Bills of Material
- Participate in internal and external audits, including inspection readiness activities
- Raise, assess and support the investigation of deviations, incidents, CAPAs and customer complaints
- Support Change Control implementation and quality risk assessments
- Assist with validation and qualification documentation review
- Support training activities related to Quality Systems and GMP/GDP compliance
- Support technology transfer, new product introduction and continuous improvement initiatives
- Contribute to GDP activities, including assessment of returns and temperature excursions
- Support annual product recall effectiveness testing
- Identify and implement opportunities for continuous improvement and efficiency
- Provide general quality support to other team members as required
Skills & Experience
- 2 years of experience previously within a QA Officer-type role.
- Minimum of a bachelor's degree in life sciences.
- Ideally, prior experience working in an on-site setting,
- Basic knowledge of Quality Systems, GMP and GDP within a pharmaceutical environment
- Understanding of pharmaceutical manufacturing and packaging operations
- Ability to interpret data and present clear, quality conclusions
- Strong communication and stakeholder‑management skills
- Computer literate (Word, Excel, PowerPoint)
Key Competencies
- Self‑motivated, professional and diplomatic
- Strong problem‑solving and decision‑making skills
- Effective time management and organisation
- Able to work collaboratively within cross‑functional teams
- Clear written and verbal communication
This role does not offer job sponsorship and requires someone based close to site due to the nature of the role being on-site.
For more information, please contact lucy.kirkaldy@cpl.com