Senior Quality Assurance Officer

An opportunity has arisen for a Band 5 Senior Quality Assurance Officer to support the Pharmaceutical Quality System within the Stockton Quality Control Laboratory. The role will contribute to ensuring compliance with Good Manufacturing Practice (GMP) and other regulatory requirements, supporting validation, audit readiness and continuous improvement of quality systems. The post holder will work closely with the Head of Quality Management & Validation and wider laboratory team to maintain inspection readiness, progress audit actions and ensure quality processes are delivered effectively.

Roles and Responsibilities

• Support the implementation and maintenance of the Pharmaceutical Quality System, including management of deviations, CAPA, change control and document control processes.
• Contribute to validation activities for equipment, facilities and systems, participate in internal and external audits, and support inspection readiness.
• Maintain training compliance, contribute to KPI reporting and support continuous improvement activities across the laboratory.
• Provide advice on quality matters and support staff in the application of GMP principles across the service.

Detailed Responsibilities

• Handle deviations, CAPA, change control, ensuring quality records are completed accurately and timely in line with data integrity principles.
• Prepare and execute protocols and reports for equipment, facilities and computerised systems as part of validation activities.
• Support audit processes through documentation preparation, participation in inspections and tracking of actions to completion.
• Maintain and update controlled documentation, support training compliance through management of training records, and assist in the delivery of GMP training where required.
• Collect and report KPI data, highlighting risks or delays where appropriate.
• Collaborate with the Senior QA team to support continuous improvement of quality processes and ensure regulatory compliance.

Qualifications and Training

• Minimum of 3 years’ experience in quality assurance within a GMP-regulated pharmaceutical or healthcare environment.
• Degree in Pharmacy, Chemistry, Pharmaceutical Sciences, Engineering or a closely related discipline.
• Completion of a Pharmaceutical GMP Auditor/Lead Auditor course.

Knowledge & Skills

• Good knowledge of GMP regulations.
• Working knowledge of current pharmaceutical quality management.
• Ability to communicate effectively to a range of professionals with conflicting priorities.
• Computer literate with excellent knowledge of Office package.
• Ability to influence and train others.
• Experience in performing validation activities in a GMP environment.

Experience

• Extensive experience in using and developing quality management systems within a regulated pharmaceutical environment.
• Experience of working in a GMP regulated environment.
• Experience of developing cost effective methods and validating methods.
• Work within a GMP inspected laboratory and working with quality systems.
• Prior exposure to microbiological methods (e.g., plate counts, broth cultures, staining, PCR) and familiarity with relevant instrumentation and quality standards.
• Previous experience of participating in MHRA inspections.