GMP Production QA Lead – Release & Compliance

PCI Pharma Services; Tredegar; On-site; GBP 26,000 - 38,000; Full time

Job summary

PCI Pharma Services in Tredegar is seeking a Quality Officer to uphold cGMP standards across manufacturing and packaging areas. You will provide QA guidance to Production and Packaging, review batch documentation, and ensure timely release of products, with a focus on continuous improvement and compliance.

You will work with Manufacturing, Packaging and Logistics to resolve quality issues, participate in audits, and support site QA leadership in ensuring regulatory compliance and product quality.

Qualifications

• Essential Knowledge: Working knowledge of cGMP standards employed at PCI.
• Experience: Experience of working in an Operational Quality environment.
• Skills and Aptitudes: High standard of written, listening and verbal communication skills.
• Proficiency with Microsoft Excel and Word; high attention to detail.

Responsibilities

• Train others in batch documentation review of critical process parameters for Manufacturing, Clinical and Packaging batches.
• Provide KPI’s for batch review and manage priorities/workload to ensure timely receipt and release.
• Perform start-up checks, Line Clearance and In-Process Checks in line with production schedules.
• Approval and inspection of Labels.
• Material checks prior to batch compilation.
• Support and drive online triage processes.
• Support Production to ensure containment actions are completed.
• Maintain the company pest control programme.
• Support GEMBA and LEAN activities within Production areas.
• Site-wide self-inspections and promote continuous improvement across all disciplines.
• Improve departmental processes to strengthen key controls and eliminate waste.

Skills

Quality Assurance

Operational Quality

Communication skills

Attention to detail

MS Excel

MS Word

Education

GCSEs including English, Maths and preferably science subjects

Tools

Microsoft Excel

Microsoft Word

Job description

PCI Pharma Services in Tredegar is seeking a Quality Officer to uphold cGMP standards across manufacturing and packaging areas. You will provide QA guidance to Production and Packaging, review batch documentation, and ensure timely release of products, with a focus on continuous improvement and compliance.

You will work with Manufacturing, Packaging and Logistics to resolve quality issues, participate in audits, and support site QA leadership in ensuring regulatory compliance and product quality.