Job Specification
PQS Officer – Pharma Quality Systems
Location: Birmingham (on‑site)
Employment Type: Permanent, full‑time
Reporting to: Head of Quality
Role Overview
We are is seeking a PQS Officer (Pharmaceutical Quality Systems Officer) to support and maintain the company’s Quality Management System (QMS) in line with UK, EU and GMP regulatory requirements.
This is a hands‑on quality systems role, ideal for someone with strong experience in CAPAs, deviations, change control and documentation, who wants to work in a regulated pharmaceutical environment and grow within Quality Assurance.
Key Responsibilities
Quality Systems & Compliance
- Support the implementation, maintenance and continuous improvement of the Pharmaceutical Quality System (PQS) in line with GMP, GDP and internal procedures
- Manage and administer deviations, CAPAs, change controls, risk assessments and complaints within the QMS
- Ensure timely investigation, documentation and closure of quality events
Documentation & Records
- Create, review and maintain SOPs, policies, forms and templates
- Ensure document control processes are followed, including version control and archiving
- Support controlled distribution of quality documents
Audits & Inspections
- Support internal audits, supplier audits and regulatory inspections (MHRA, FDA, EMA as applicable)
- Track audit actions and ensure follow‑up CAPAs are implemented effectively
- Support readiness activities for inspections
Training
- Support the GMP training programme, including tracking completion and maintaining training records
- Assist with onboarding and refresher training relating to quality systems
Quality Support
- Provide day‑to‑day quality systems support to operational, technical and supply chain teams
- Assist with management review inputs, quality metrics and KPI reporting
- Support external partners and CMOs where required from a quality systems perspective
Skills & Experience Required
Essential
- Experience working in a pharmaceutical, biotech or regulated life sciences environment
- Proven exposure to Quality Systems (PQS, QMS, eQMS or paper‑based systems)
- Working knowledge of GMP (EU & UK preferred)
- Experience managing or supporting:
- Deviations
- CAPAs
- Change Controls
- Document Control
- Strong attention to detail and high standards of documentation
- Confident communicator with the ability to work cross‑functionally
Desirable
- Experience with E QMS platforms (Veeva, Track Wise, Master Control or similar)
- Exposure to audits or regulatory inspections
- Background supporting commercial pharma operations or virtual/outsourced models
Qualifications
- Degree or equivalent in Life Sciences, Pharmacy, Chemistry or a related discipline (preferred)
- Formal GMP training (essential)