GMP QA Officer – Compliance & Audits

PCI Pharma Services; Bridgend; On-site; GBP 42,000 - 56,000; Full time

Job summary

PCI Pharma Services Bridgend, UK is seeking a Quality Assurance Officer to support certification and release of medicinal products in line with regulatory and project requirements. You will maintain the Pharmaceutical Quality System and host audits.

The role requires strong GMP knowledge, effective communication, and the ability to coordinate projects, perform internal and external audits, and drive continuous improvement within the quality function.

Qualifications

• Good GMP knowledge and experience of EU legislation and guidelines; experience with FDA GMP requirements CFR 210 and 211 other regulatory guidelines preferable.
• Strong communication skills.
• The ability to introduce, co-ordinate, complete and report on projects.
• A high level of self-motivation is required.
• Excellent written and verbal communication.
• Ability to perform audits, internally and externally.

Responsibilities

• Support the QP in execution of their legal and operational duties.
• Administration, control and support core systems within the Pharmaceutical Quality system as allocated by line manager. Including but not limited to Internal audits, vendor management, deviations/complaints, CAPA, change control and document control.
• Reporting of metrics for systems within scope of responsibility.
• Support and host client audits of the PCI Bridgend facility.
• Support delivery of site/departmental projects and objectives.
• Support continuous improvement, validation and technical services activities.
• Author standard operating procedures.
• Provide QA and GMP related training.
• Schedule, host and close out client audits.
• Pre-certification assessment of batch records and generation of draft QP certificates.
• Post QP certification batch release via the inventory system.
• Review and approval of offsite shelf life extension labelling activities.
• Pre-approval assessment of change controls and deviations.
• Co-ordinate and perform investigations into internal and external quality issues.
• Assess temperature excursions during shipment in line with the stability priofile of the product(s).
• Approval of completed investigations, CAPA’s and change controls.
• Schedule, perform and close out internal and external audits within established timelines.
• Pre review of validation/qualification protocols.

Skills

GMP knowledge

Regulatory knowledge

Auditing

Communication skills

Project coordination

Self-motivation

Interpersonal skills

Decision making

Education

HNC/HND or degree in life sciences

Tools

Microsoft Office

Job description

PCI Pharma Services Bridgend, UK is seeking a Quality Assurance Officer to support certification and release of medicinal products in line with regulatory and project requirements. You will maintain the Pharmaceutical Quality System and host audits.

The role requires strong GMP knowledge, effective communication, and the ability to coordinate projects, perform internal and external audits, and drive continuous improvement within the quality function.