Quality Assurance Officer: GMP/GDP Compliance & Improvement

Clinigen Group; Byfleet; Presencial; GBP 32 000 - 42 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

27 days holiday plus 8 bank holidays

Pension contributions 4.5% matched

Life assurance 4 x annual salary

Flexible Benefits Platform with £25月/£

Resumo da oferta

Clinigen Group is seeking a proactive Quality Officer to support GMP/GDP compliance and QMS processes within our Quality and Warehouse teams. You will help safeguard product quality and patient safety while collaborating with cross-functional groups to embed quality standards across the business.

The role focuses on maintaining QMS documentation, coordinating audits, managing records, and driving improvements. Strong attention to detail, effective communication and independent work are essential.

Qualificações

• Degree in Life Sciences, Pharmacy, Pharmacology, Chemistry or a related scientific discipline preferred.
• Experience in a Quality Assurance or similar role within a regulated environment.
• Good working knowledge of GMP and GDP requirements and quality systems.
• Understanding of WDA(H), MS and MIA(IMP) licence requirements.
• Strong communication skills with stakeholders at all levels.
• Excellent organisational, administrative and IT skills, with the ability to manage changing priorities and meet deadlines.
• Proactive, solutions-focused approach with strong attention to detail, accountability and the ability to work independently and as part of a team.

Responsabilidades

• Maintain GMP and GDP Compliance - Support the Quality team in ensuring compliance with GMP, GDP and internal quality standards.
• Support the Quality Management System (QMS) - Manage and maintain QMS records, including change controls, non-conformances, CAPAs, risk assessments and quality documentation.
• Coordinate Audits and Quality Activities - Support the client audit programme, including audit scheduling, observations tracking and responses.
• Drive Continuous Improvement - Produce quality reports, analyse trends and data, identify improvement opportunities, and support process enhancements.
• Investigate Quality Issues and Complaints - Work with internal teams to investigate quality concerns and implement corrective actions.
• Manage Quality Documentation and Training - Assist with SOPs, work instructions and quality forms, supporting QMS training.
• Collaborate with Stakeholders and Support Projects - Build relationships with suppliers, customers, and internal stakeholders on quality projects.

Conhecimentos

GMP knowledge

GDP knowledge

QA experience

Strong communication

IT skills

Attention to detail

Formação académica

Degree in Life Sciences / Pharmacy / Pharmacology / Chemistry

Descrição da oferta de emprego

Clinigen Group is seeking a proactive Quality Officer to support GMP/GDP compliance and QMS processes within our Quality and Warehouse teams. You will help safeguard product quality and patient safety while collaborating with cross-functional groups to embed quality standards across the business.

The role focuses on maintaining QMS documentation, coordinating audits, managing records, and driving improvements. Strong attention to detail, effective communication and independent work are essential.