Quality Assurance Officer

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.

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