Quality Assurance Officer

Walker Cole International Ltd; Cardiff; On-site; GBP 35,000 - 45,000; Full time

Job summary

Walker Cole International is seeking a Quality Assurance Officer on a 12-month fixed term contract in Wales. The role sits in a GMP-regulated manufacturing environment and involves day-to-day quality compliance, documentation review, deviations, CAPAs, change control, and audit support.

You will work across Production, Quality Control and Regulatory teams, ensuring batch release readiness and continued QMS improvement.

Qualifications

• QA experience in GMP-regulated pharma/biotech manufacturing.
• Strong understanding of QMS, GMP and pharmaceutical standards.
• Experience managing deviations, CAPAs and Change Controls.
• Experience supporting audits or regulatory inspections.
• Excellent communication and organisational skills.

Responsibilities

• Support the maintenance and improvement of the site's Quality Management System (QMS) in line with GMP/regulatory requirements.
• Review and approve batch documentation, ensuring accuracy and compliance prior to release.
• Manage and investigate deviations, non-conformances and CAPAs, including root cause analysis.
• Support Change Control processes and maintain controlled quality documentation (SOPs, specifications).
• Participate in internal and external audits, including regulatory inspections.
• Support supplier and vendor qualification activities.
• Monitor quality metrics, support training compliance, and contribute to continuous improvement initiatives.

Skills

Quality Assurance experience

GMP knowledge

Documentation management

CAPA & deviations handling

Audit support experience

Communication & organisation

Education

Scientific degree in pharmaceutical field

Job description

ROLE BRIEF: Quality Assurance Officer - 12 Month FTC

Location: Wales

Salary: £35,000–£45,000 DOE

Contract: 12 months, Fixed Term

Walker Cole International is supporting a well-established pharmaceutical manufacturing organisation in the search for a Quality Assurance Officer to join their Quality team on a 12-month Fixed Term Contract, based in Wales.

This is an excellent opportunity to join a GMP-regulated manufacturing environment, playing a key role in maintaining day-to-day quality compliance and supporting the site's Quality Management System. It offers broad, hands-on exposure across documentation, deviations, CAPAs, change control and audit support, working closely with Production, Quality Control and Regulatory teams.

This role would suit a QA professional looking to build on their GMP experience within a well-established manufacturing site, or someone seeking a structured contract opportunity with the potential for extension.

You will be responsible for:

• Supporting the maintenance and continuous improvement of the site's Quality Management System in line with GMP and regulatory requirements.


• Reviewing and approving batch documentation, ensuring accuracy and compliance prior to release.


• Managing and investigating deviations, non-conformances and CAPAs, including root cause analysis.


• Supporting Change Control processes and maintaining controlled quality documentation, including SOPs and specifications.


• Participating in internal and external audits, including regulatory inspections.


• Supporting supplier and vendor qualification activities.


• Monitoring quality metrics, supporting training compliance, and contributing to continuous improvement initiatives.


• Liaising with cross-functional teams to resolve quality issues in a timely manner.

The successful candidate will have:

• Previous Quality Assurance experience within a GMP-regulated pharmaceutical or biotechnology manufacturing environment.


• A good understanding of Quality Management Systems, GMP and pharmaceutical quality standards.


• Experience managing or supporting deviations, CAPAs, Change Controls and controlled documentation.


• Experience supporting audits or regulatory inspections.


• Excellent communication and organisational skills, with the ability to work across multiple departments.


• A scientific degree or equivalent experience within the pharmaceutical industry.

Quality Assurance | QA | QA Officer | GMP | Good Manufacturing Practice | Quality Management System | QMS | CAPA | Deviations | Change Control | Batch Release | Internal Audit | Regulatory Compliance | Pharmaceutical | Biotechnology | Fixed Term Contract | Wales