Quality Assurance Officer – Pharmaceuticals (GDP)
Overview
Our client is looking for a proactive and detail-focused Quality Assurance Officer to support a busy pharmaceutical quality function. This role will play a key part in maintaining GDP compliance, supporting the Quality Management System (QMS), and ensuring regulatory standards are consistently met.
You will work closely with the QA Manager / Responsible Person (RP) and will have the opportunity to deputise when required.
Key Responsibilities
Quality Management System (QMS)
Support the ongoing maintenance and improvement of the QMS
Manage QA logs including deviations, CAPAs, change controls, complaints, recalls, and SOP tracking
Assist with implementation and maintenance of electronic QMS systems
Ensure all quality documentation is correctly issued, controlled, and archived
Compliance & Regulatory
Ensure compliance with GDP and relevant regulatory requirements (MHRA, EU guidelines)
Support supplier and customer qualification activities
Assist in ensuring all licensed activities (procurement, storage, distribution, export) remain compliant
Deviations, CAPAs & Investigations
Log, investigate, and track deviations, CAPAs, complaints, and temperature excursions
Support root cause analysis and risk assessments
Ensure timely completion of corrective and preventative actions
Documentation & SOPs
Draft, review, and update Standard Operating Procedures (SOPs)
Maintain accurate and up-to-date quality documentation, including training records and validation files
Audits & Inspections
Support internal audits, self-inspections, and external audits
Assist with supplier/vendor audits and compliance checks
Review returned goods, damaged stock, and support recall processes
Training & Reporting
Support GDP training activities and maintain training records
Attend quality review meetings and provide documentation support
Assist in preparing quality metrics and reports
Additional Responsibilities
Support change control processes and risk assessments (ICH Q9)
Liaise with manufacturers and external stakeholders on quality matters
Ensure compliance with Health & Safety and internal procedures
Support wider QA activities as required
Experience & Qualifications
Degree in Life Sciences (or equivalent, RQF Level 6 or above)
Previous experience or understanding of GDP/GMP within pharmaceuticals
Familiarity with MHRA, EU GDP guidelines, and quality systems
Strong organisational and documentation skills
Comfortable using Microsoft Office (Excel, Word, Outlook)
Key Skills
High attention to detail
Strong written and verbal communication
Ability to manage multiple priorities
Problem-solving mindset
Team-oriented with a proactive approach