Quality Officer at Clinigen
London, Essex - England, United Kingdom -
Full Time


Start Date

Immediate

Expiry Date

10 Nov, 26

Salary

55000.0

Posted On

03 Oct, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Industry

Pharmaceutical Manufacturing

Description

Key Responsibilities:


  • Maintain GMP and GDP Compliance - Support the Quality team in ensuring compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (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, coordination, tracking observations and assisting with responses and corrective actions
  • Drive Continuous Improvement - Produce quality reports, analyse trends and data, identify improvement opportunities, and support the implementation of process enhancements across the business
  • Investigate Quality Issues and Complaints - Work with internal teams, customers and suppliers to investigate quality concerns, identify root causes, and implement effective corrective and preventive actions
  • Manage Quality Documentation and Training - Assist with the creation, review and approval of SOPs, work instructions and quality forms, while supporting the delivery of QMS-related training to employees
  • Collaborate with Stakeholders and Support Projects - Build effective relationships with suppliers, customers, clients and internal stakeholders, contributing to business projects and providing ongoing support to the wider Quality team

Key Requirements:


  • 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 the ability to work effectively 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

Responsibilities

Key Responsibilities:


  • Maintain GMP and GDP Compliance - Support the Quality team in ensuring compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (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, coordination, tracking observations and assisting with responses and corrective actions
  • Drive Continuous Improvement - Produce quality reports, analyse trends and data, identify improvement opportunities, and support the implementation of process enhancements across the business
  • Investigate Quality Issues and Complaints - Work with internal teams, customers and suppliers to investigate quality concerns, identify root causes, and implement effective corrective and preventive actions
  • Manage Quality Documentation and Training - Assist with the creation, review and approval of SOPs, work instructions and quality forms, while supporting the delivery of QMS-related training to employees
  • Collaborate with Stakeholders and Support Projects - Build effective relationships with suppliers, customers, clients and internal stakeholders, contributing to business projects and providing ongoing support to the wider Quality team

Key Requirements:


  • 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 the ability to work effectively 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

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