QA Systems Lead – Pharma Quality & Compliance

Accord Healthcare; Barnstaple; Hybrid; GBP 52,000 - 64,000; Full time

Benefits offered by this job

25 days’ holiday + bank holidays

Bonus scheme

Company pension scheme

Job summary

Accord Healthcare Europe seeks a methodical Quality Assurance Officer – Systems to support, improve and maintain our Pharmaceutical Quality Systems (PQS) in line with EU GMP and corporate standards. You’ll investigate issues, liaise with SMEs and suppliers, and drive continuous improvement across QC processes.

You’ll review QA documentation, support system training, and help deliver quality reporting while ensuring compliance throughout manufacturing, packaging and testing operations.

Qualifications

• Experience with Pharmaceutical Quality Systems and knowledge of Quality regulations.
• Prior QA experience or extensive PQS usage in manufacturing.
• Experience managing investigations, CAPA, change controls and audits would help.

Responsibilities

• Oversee and maintain the Pharmaceutical Quality System (PQS); drive continuous improvement.
• Lead investigations and CAPA closures with stakeholders and CMOs/packagers.
• Manage product quality complaint investigations and escalation processes.
• Review and approve Change Controls, CAPAs, quality risk assessments and documentation.
• Provide quality oversight of supply chains and third‑party providers for GMP compliance.
• Maintain Technical Agreements, Regulatory Compliance Files and supplier quality documents.
• Oversee regulatory documentation including dossiers and Module 3 submissions.
• Support preparation, review and approval of Product Quality Reviews (PQRs).
• Liaise with regulatory authorities, customers and suppliers on quality matters.
• Lead cross‑functional quality improvement projects to enhance compliance and product quality.

Skills

Pharmaceutical quality systems

Quality regulations

Investigations / root cause analysis

IT skills / Microsoft Office

Communication skills

Organisation / multi‑tasking

Job description

Accord Healthcare Europe seeks a methodical Quality Assurance Officer – Systems to support, improve and maintain our Pharmaceutical Quality Systems (PQS) in line with EU GMP and corporate standards. You’ll investigate issues, liaise with SMEs and suppliers, and drive continuous improvement across QC processes.

You’ll review QA documentation, support system training, and help deliver quality reporting while ensuring compliance throughout manufacturing, packaging and testing operations.