CyberscopeTV

About the job

QA Compliance Lead - Pharma - Contract - South West Our client is a leading biopharma manufacturing organisation. At present they are seeking a QA Compliance Lead on an initial 6 month contract basis to provide oversight to Validation documentation. Responsibilities; • Lead the QMS & Compliance teams to deliver compliant Quality systems, and develop a world-class QMS; • Develop and manage the QA, GMP, & QMS programmes, policies, standards, and procedures to ensure conformance to the highest standards and regulatory agency requirements (MHRA, EU, FDA etc.); • Establish processes and systems that support collaboration, compliance and are simple and effective; • Lead and support where required with regulatory inspections; • Further develop, implement and manage processes that align with, and drive, effective systems for change control, deviations and investigations, complaints, recalls, risk management and CAPA; • Oversee GMP Quality system performance metrics, analyse compliance data and coordinate the necessary Quality reporting and escalation responses; • Manage the processes for the Quality Management Review Board, Change Control Review Board and Risk Management forums; • Provide expertise and guidance to senior management in the interpretation of global GMP regulations, ICH guidelines and internal policies and procedures; • Promote continuous improvements in quality systems and department infrastructure

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Wiltshire,United Kingdom