Quality Assurance Specialist – GMP & Compliance

PCI TRGR Penn Pharmaceutical Services Ltd; Wales; On-site; GBP 40,000 - 60,000; Full time

Job summary

PCI Pharma Services in Bridgend is seeking a QA Officer to support certification and release of medicinal products under GMP guidelines. The role maintains and improves the Pharmaceutical Quality System and collaborates with the QP on regulatory compliance.

You will be involved in audits, CAPA, change control, document control, and QA training, with opportunities to contribute to continuous improvement and project delivery.

Qualifications

• Essential GMP knowledge and experience of EU legislation and guidelines; experience with FDA GMP CFR 210 and 211 is preferred.
• Excellent written and verbal communication. Ability to report on projects and communicate at all levels.

Responsibilities

• Support the QP in execution of their duties.
• Administer and support core processes within the Pharmaceutical Quality System.
• Lead internal audits, vendor management, deviations/complaints, CAPA, change control and document control.
• Report metrics for systems within scope and support client audits of the Bridgend facility.
• Coordinate investigations into internal and external quality issues.
• Review and approve completed investigations, CAPA and change controls.

Skills

GMP knowledge

Regulatory knowledge (EU/FDA)

Auditing

Communication skills

Project coordination

Self-motivation

Education

Life sciences degree or equivalent

QA experience in pharma

Regulated industry experience

Tools

MS Office

QMS software/Documentation systems

Job description

PCI Pharma Services in Bridgend is seeking a QA Officer to support certification and release of medicinal products under GMP guidelines. The role maintains and improves the Pharmaceutical Quality System and collaborates with the QP on regulatory compliance.

You will be involved in audits, CAPA, change control, document control, and QA training, with opportunities to contribute to continuous improvement and project delivery.