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)