Steve Hill
Principal Quality Manager Csv Project Manager @Waters Corporation
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WORK HISTORY
Principal Quality Manager Csv Project Manager @Waters Corporation
Global CSV /CSA expert within the Waters Corporation. Process Owner for the GxP IT CSV/CSA for Production, Manufacturing and Quality Management Systems and Regulatory Compliance. System Owner for the GxP Compliant Systems Inventory. Consultant on Production Systems - MES, PCS, LIMS and PIMS. GAMP, Quality Assurance Auditor: FDA, MHRA, BSI lead auditor ISO 9001, and ISO 13485, ISO 27001. Experienced in CAPA Process, CRO/CMO Vendor /supplier management specialist, Clinical Systems /Clinical Trials, ICH Quality
EDUCATION
The University of Manchester
Physiology and Pharmacology BSc, Phamaceuticals
SKILLS
ABOUT STEVE HILL
Quality/Project IT/IS manager in a regulated Pharmaceutical (Clinical & pre-clinical, Manufacturing) and Medical Device implementing GCP, GMP, GLP, ISO 9001, ISO 13485, ISO 27001. Extensive experience of implementing and maintaining the compliance of On-premise & Cloud systems (ERP, MES, MIMS, PIMS & LIMS and QMS Doc management and Change Management Systems) and processes that contribute to and support drug (NDA) and medical device (510k or PMA) submissions according to FDA guidelines (21CFR11, CDISC and SEND), MHRA UK GxP, ICH and ISPE GAMP5. Delivery focused PM (PRINCE 2, PMI), Quality Manager (ISO, RQA), Process & System Owner of IS systems and business processes within a GXP regulated environment (21CFR820, SOPs and work instructions). Coordinated internal and external regulatory audits and inspections against Validation Master Plans. I have capitalised on my clinical drug development expertise to significantly improve the regulatory QMS policies and procedures in line with iso 9001.Active GAMP UK memberExtensive consultancy experience at exec level with CROs and CMOs to implement QMSIS Vendor Audits for Cloud IaaS/PaaS/SaaS. ISO 9001 BSI Lead AuditorISO 27001 AuditorSupply Chain Management SAP ERP- Supplier Qualification CMO and CROPerformed coordination of MHRA and FDA inspections of Critical GXP systemsCSV and CSA experience aligned to FDA guidelines, GAMP5-GXP, Annex 11Information Systems Development Lifecycle experience, Waterfall, Agile / Scrum. DevOps and IT operations collaborationData Integrity standards (ALCOA+)FDA and MHRA,COTS, Software Development: V-Model, Agile Scrum, iterative developmentSAP ERP, SAP APO, SAP SuccessFactors LMS training, Veeva Vault Navex Global PolicytechSoftware Verification and Validation IEC 62304Software Static and Dynamic Testing ToolsEquipment ValidationProcess ValidationMethod ValidationCAPAChange Control systems: TrackWise and MasterControlMedical Device IVD experience ISO ISO13485 & ISO17025 guidelines and AuditGovernance, Risk & Compliance Audit experienceMedical Device software tool development and validation IEC 62304Prince 2 reg no.99••••••••41Business Analysis (BABOK)ITIL v3 foundationCIMA training- on fundamentals of Management Accounting and Sarbanes-Oxley Internal Control SystemsBCS ISEB Information Systems Development and Business Analyst CISA ISACA trainingRAPS member: 96•••42RQA reg no.
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