To act as the Validation Subject Matter Expert (SME) within the MMC, providing leadership in all validation activities to ensure they are all carried out in compliance with EU GMP. To introduce and manage core Pharmaceutical Quality Systems (PQS) in relation to equipment management i.e. Validation Master Plan (VMP), New equipment introduction processes,equipment validation, revalidation, repairs, planned preventative maintenance (PPM), Permit to work (PTW). To lead Outsourced Activity management of contractors e.g.
supplier approval of contractors, Quality Technical Agreements, Monitoring of outsourced activity reporting system and supplier review. To introduce and manage core Pharmaceutical Quality Systems (PQS) in relation to New Product Introduction and act as the Quality Risk Management (QRM) lead for process design e.g. Critical Process Parameters (CPP) / Critical Quality Attributes (CQA) and Product Quality Reviews (PQR). To provide specialist QA oversight of Process Validations such as Aseptic Process Simulation (APS), operator validation, gowning validation, transfer disinfection, cleaning validation / residue testing, transport validation, temperature mapping, container / closure validation and QC method validation in collaboration with the Quality Control and Production teams.
To lead the site wide approach to computerised system validation and data integrity GMP requirements. To oversee the Contamination Control Strategy (CCS) and environmental monitoring programme in collaboration with the Site Microbiologist and the wider team. To build and manage the QA capacity planning. To manage and oversee unit crisis management procedures and planned, and unplanned site shutdown.
To manage the QA validation team, consisting of validation specialists and computerised system validators. To develop and execute training plans for QA validation team. Deliver training on relevant QA systems site wide. To role model compassionate and inclusive leadership in order to shape the creation of a collective leadership culture within the trust.
This means demonstrating a consistent leadershipstyle which (a) engages, enables and empowers others (b) uses coaching to promote ownership of learning and quality improvement and (c) facilitates team working and collaboration within teams / departments and across organisational boundaries

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