Quality Management System (QMS) Maintain and support the organisation’s Quality Management System in accordance with GMP requirements. Ensure laboratory procedures, policies, and documentation are compliant with regulatory expectations. Support continuous improvement of quality systems and compliance processes. Documentation and Compliance Review analytical records, laboratory data, and documentation for GMP compliance. Ensure that all laboratory records meet regulatory data integrity requirements. Manage controlled documents including SOPs, policies, and quality procedures. Deviations, CAPA and Investigations Manage and investigate deviations, non-conformances, and quality incidents. Coordinate root cause analysis and implement Corrective and Preventive Actions (CAPA). Support investigations relating to Out-of-Specification (OOS) or Out-of-Trend (OOT) results. Regulatory Compliance Ensure laboratory operations comply with applicable regulatory requirements including expectations of the Medicines and Healthcare products Regulatory Agency and international GMP standards. Support regulatory inspections, internal audits, and compliance reviews. Change Control and Risk Management Review and approve change control documentation. Conduct quality risk assessments relating to laboratory processes and procedures. Training and Quality Culture Support the development and delivery of GMP and quality-related training programs. Promote a strong culture of quality and regulatory compliance within the organisation. Required Qualifications Bachelor’s or higher degree in Pharmaceutical Sciences, Chemistry, Life Sciences, or a related discipline. Required Skills and Experience Experience working within a pharmaceutical or GMP-regulated environment. Knowledge of pharmaceutical quality systems and regulatory requirements. Familiarity with data integrity principles and laboratory documentation standards. Strong analytical, problem-solving, and documentation skills.