To provide QA oversight of the end-to-end product manufacturing process, ensuring compliance with pharmaceutical GMP, and Food and Feed quality standards; managing the shop floor quality team and batch release process, offering technical expertise, guidance, and leadership in all operational quality aspects.
Main Responsibilities:
Shop Floor Leadership
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Lead, coach, and mentor the QA operations team on the shop floor.
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Promote a strong quality culture, accountability, and right-first-time principles.
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Ensure effective QA presence and decision-making within production areas.
Technical Expertise
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Act as a subject matter expert for quality and compliance issues.
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Provide guidance to QA and production teams on complex quality challenges.
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Support troubleshooting and resolution of technical and process-related issues.
Regulatory Compliance
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Ensure full compliance with EU/UK pharmaceutical GMP regulations and food/feed safety standards.
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Monitor manufacturing practices to ensure adherence to approved procedures and regulatory requirements.
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Support regulatory inspections and external audits as required.
Batch Release
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Manage the batch release process, ensuring all products meet quality and compliance standards.
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Review batch manufacturing and packaging records for accuracy and completeness.
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Approve or reject product batches based on compliance with specifications and GMP requirements.
Non-Conformances and CAPA
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Lead and support investigations into deviations and non-conformances.
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Conduct root cause analysis and ensure effective corrective and preventive actions (CAPAs) are implemented.
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Track CAPA effectiveness and ensure timely closure.
Annual Product Quality Review (APQR)
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Manage and deliver the annual product quality review process.
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Analyse quality trends, deviations, complaints, and performance data.
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Identify improvement opportunities and ensure ongoing compliance with regulatory expectations.
Document Review and Approval
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Review and approve quality and technical documentation, including SOPs, specifications, validation protocols, and reports.
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Ensure documentation is accurate, compliant, and aligned with current regulatory and operational requirements.
Quality Metrics and Reporting
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Develop, monitor, and report KPIs related to quality performance.
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Use data analytics to identify trends, risks, and opportunities for improvement.
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Present quality performance updates to senior management.
Cross-Functional Collaboration
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Work closely with Production, Technical, Supply Chain, and Regulatory Affairs teams.
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Drive alignment on quality objectives and continuous improvement initiatives.
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Support new product introductions, process changes, and validation activities.
Training and Development
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Identify training needs and deliver targeted development programs for the QA team.
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Ensure all QA personnel are trained and competent in GMP and quality systems.
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Support ongoing professional development and succession planning.
Continuous Improvement
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Lead initiatives to improve quality systems, processes, and performance.
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Embed a continuous improvement mindset using structured problem-solving methodologies.
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Drive efficiency while maintaining compliance and product quality.
