• Lead, coach, and mentor the QA operations team on the shop floor.
• Promote a strong quality culture, accountability, and right-first-time principles.
• Ensure effective QA presence and decision-making within production areas.

• Act as a subject matter expert for quality and compliance issues.
• Provide guidance to QA and production teams on complex quality challenges.
• Support troubleshooting and resolution of technical and process-related issues.

• Ensure full compliance with EU/UK pharmaceutical GMP regulations and food/feed safety standards.
• Monitor manufacturing practices to ensure adherence to approved procedures and regulatory requirements.
• Support regulatory inspections and external audits as required.

• Manage the batch release process, ensuring all products meet quality and compliance standards.
• Review batch manufacturing and packaging records for accuracy and completeness.
• Approve or reject product batches based on compliance with specifications and GMP requirements.

• Lead and support investigations into deviations and non-conformances.
• Conduct root cause analysis and ensure effective corrective and preventive actions (CAPAs) are implemented.
• Track CAPA effectiveness and ensure timely closure.

• Manage and deliver the annual product quality review process.
• Analyse quality trends, deviations, complaints, and performance data.
• Identify improvement opportunities and ensure ongoing compliance with regulatory expectations.

• Review and approve quality and technical documentation, including SOPs, specifications, validation protocols, and reports.
• Ensure documentation is accurate, compliant, and aligned with current regulatory and operational requirements.

• Develop, monitor, and report KPIs related to quality performance.
• Use data analytics to identify trends, risks, and opportunities for improvement.
• Present quality performance updates to senior management.

• Work closely with Production, Technical, Supply Chain, and Regulatory Affairs teams.
• Drive alignment on quality objectives and continuous improvement initiatives.
• Support new product introductions, process changes, and validation activities.

• Identify training needs and deliver targeted development programs for the QA team.
• Ensure all QA personnel are trained and competent in GMP and quality systems.
• Support ongoing professional development and succession planning.

• Lead initiatives to improve quality systems, processes, and performance.
• Embed a continuous improvement mindset using structured problem-solving methodologies.
• Drive efficiency while maintaining compliance and product quality.

• In-depth knowledge of EU/UK GMP regulations and guidelines.
• Strong problem-solving and analytical skills.
• Excellent leadership and team management skills.
• Excellent communication and interpersonal skills.
• Detail-oriented with a focus on continuous improvement.
• Proven track record of maintaining high-quality standards in a GMP environment.
• Ability to handle multiple projects and priorities simultaneously.

• Bachelor's degree in a related field
• Minimum 4 years' experience in quality assurance or quality control in a pharmaceutical manufacturing environment, with 2 years' experience in a management role
• Experience of HACCP preferred

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