GMP/GDP Quality Release Specialist

Clinigen; Byfleet; On-site; GBP 42,000 - 56,000; Full time

Benefits offered by this job

27 days holiday

Pension matching

Life assurance 4x salary

Flexible Benefits Platform (£25/mo)

Annual salary review

Independent financial advice

Enhanced Employee Assistance Programme

Shopping discounts

Long service awards

Recognition scheme

Job summary

Clinigen is seeking a proactive and detail-driven Quality Release Specialist to support GMP/GDP compliance, the Quality Management System, and product quality and patient safety. You will collaborate with cross-functional teams, external partners and regulators, creating and reviewing quality documentation, managing quality records, audits and CAPAs.

The role requires a life sciences degree and QA experience, strong IT skills, and a disciplined, solution‑focused approach to regulatory

Qualifications

• Degree in Life Sciences, Pharmacy or Chemistry (or equivalent).
• Experience in a Quality Assurance or related role.
• Knowledge of GMP and GDP guidelines for human medicinal products.
• Understanding of WDA(H), MS and MIA(IMP) licence requirements.
• Strong organisational, planning and administrative skills.
• Excellent IT skills, particularly Microsoft Office.
• Confident communicator, able to engage at all levels.
• Solutions‑focused with the ability to adapt and manage changing priorities.
• High levels of accountability, accuracy and attention to detail.

Responsibilities

• Manage day-to-day activities within the Quality Management System (QMS), partnering with cross-functional teams to investigate, review and close quality records within the electronic QMS.
• Create, review and approve quality documentation, including SOPs, work instructions and forms, ensuring compliance with Good Documentation Practice.
• Maintain GMP and GDP standards, managing accurate paper and electronic quality records in line with company procedures and regulatory requirements.
• Investigate quality issues and customer complaints, working collaboratively to identify root causes, prioritise actions and implement pragmatic, compliant solutions.
• Communicate quality system requirements effectively to employees, support quality-related training, and influence others to achieve quality objectives.
• Support internal, external and regulatory audits and inspections, including preparation, participation and completion of corrective and preventative actions (CAPAs).
• Drive continual improvement by analysing quality data, identifying process improvement opportunities, acting as a Quality stakeholder on projects, managing key supplier relationships, escalating risks to management, and supporting the wider Quality team as needed.

Skills

Quality assurance

GMP knowledge

GDP knowledge

QMS

Regulatory communication

Documentation

Analytical skills

Education

Degree in Life Sciences/Pharmacy/Chemistry

Tools

Microsoft Office

Job description

Clinigen is seeking a proactive and detail-driven Quality Release Specialist to support GMP/GDP compliance, the Quality Management System, and product quality and patient safety. You will collaborate with cross-functional teams, external partners and regulators, creating and reviewing quality documentation, managing quality records, audits and CAPAs.

The role requires a life sciences degree and QA experience, strong IT skills, and a disciplined, solution‑focused approach to regulatory