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)