GMP Quality Assurance Specialist

PCI Pharma Services; Wales; On-site; GBP 52,000 - 68,000; Full time

Job summary

PCI Pharma Services in Bridgend, Wales, is seeking a Quality Assurance professional to certify and release medicinal products and to maintain the Pharmaceutical Quality System. This role supports internal audits, deviations, CAPA, change control and document control.

The successful candidate will assist the QP, manage audits, generate metrics, and contribute to continuous improvement while ensuring compliance with EU and FDA guidelines.

Qualifications

• Good GMP knowledge and experience with EU legislation and guidelines.
• Strong communication skills and ability to report clearly.
• Ability to lead projects and coordinate across teams.

Responsibilities

• Support the QP in execution of legal and operational duties.
• Administer and support core systems within the Pharmaceutical Quality system.
• Participate in internal audits, deviations, CAPA and change control.
• Report metrics for systems within scope of responsibility.
• Host client audits and coordinate site/departmental projects.
• Author SOPs and provide QA training.

Skills

GMP knowledge

Auditing experience

Regulatory knowledge

Communication skills

Project coordination

Education

HNC/HND or degree in life sciences

Job description

PCI Pharma Services in Bridgend, Wales, is seeking a Quality Assurance professional to certify and release medicinal products and to maintain the Pharmaceutical Quality System. This role supports internal audits, deviations, CAPA, change control and document control.

The successful candidate will assist the QP, manage audits, generate metrics, and contribute to continuous improvement while ensuring compliance with EU and FDA guidelines.