Quality Assurance Specialist

Quality Assurance Specialist Role Overview We are seeking a Quality Assurance professional to join the Quality function supporting the compliant handling, storage and distribution of medicines and vaccines. The role covers a broad range of GxP quality activities across Supply, with a particular focus on deviations, CAPA, change control, risk management, documentation and equipment qualification. The successful candidate will work independently as well as collaboratively with colleagues across Quality, Supply, technical functions and external partners to maintain and continuously improve compliant processes, equipment, facilities and documentation. Key Responsibilities

• Investigate and manage deviations, including root cause analysis, CAPA development, implementation and effective follow-up.
• Prepare, coordinate and follow up on change controls, ensuring appropriate assessment, approval and implementation.
• Prepare, review and maintain GxP procedures, SOPs, work instructions and other controlled documentation.
• Participate in risk assessments and impact assessments relating to processes, equipment, systems and quality activities.
• Conduct periodic evaluations of equipment, systems and processes, identifying potential compliance risks and improvement opportunities.
• Track quality activities, observations, actions and deadlines, ensuring timely and effective completion.
• Support self-inspections, internal and external audits and regulatory inspections, including preparation and follow-up of observations.
• Provide GxP training, guidance and professional support to operational employees.
• Contribute to continuous improvement initiatives and the development of quality processes and workflows.
• Participate in cross-functional projects and implementation of changes impacting the Supply Quality function.

Qualification Responsibilities The role will also have a dedicated area of responsibility for equipment and facility qualification, ensuring that relevant systems are appropriately documented, qualified and maintained in a state of control. Responsibilities will include:

• Planning and coordinating qualification and requalification activities.
• Preparing and reviewing requirements specifications, risk assessments, qualification protocols, test plans and qualification reports.
• Participating in the execution and documentation of IQ, OQ and PQ activities.
• Reviewing test results, acceptance criteria and qualification deviations.
• Monitoring the qualified status of equipment and identifying requirements for requalification.
• Working closely with QA, Engineering, technical functions and external suppliers throughout qualification activities.

The scope may include refrigeration and freezing facilities, temperature monitoring systems, alarm systems, transport equipment and temperature-controlled transport solutions. Candidate Profile

• Experience in Quality Assurance within a GMP/GxP-regulated pharmaceutical, biotechnology, vaccine or healthcare environment.
• Strong practical experience with deviations, investigations, CAPA and change control.
• Experience preparing and maintaining GMP/GxP documentation.
• Practical experience with qualification and validation, ideally including IQ/OQ/PQ.
• Experience with risk assessments, impact assessments and equipment lifecycle activities.
• Experience supporting audits, inspections and continuous improvement initiatives.
• Strong organisational and communication skills, with the ability to work independently and cross-functionally.