Keval Tanna
About
Keval Tanna is from Greater Reading Area. Keval works in the following industries: "Pharmaceutical Manufacturing". Keval is currently Director, Computer Systems Quality, Global Quality Operations at Pfizer, located in United Kingdom. In Keval's previous role as a Senior Manager Validation, Global Quality Operations at Pfizer, Keval worked in Maidenhead until Dec 2019. Prior to joining Pfizer, Keval was a Senior Specialist, CSQA EMEA at Wyeth and held the position of Senior Specialist, CSQA EMEA at Maidenhead. Prior to that, Keval was a QA Validation Manager, EMEA at Stiefel Laboratories, based in Maidenhead from Sep 2005 to Oct 2008. Keval started working as IT Quality & Compliance Specialist at Evotec AG in Didcot in Jun 2002. From Jan 2001 to Jun 2002, Keval was Validation Engineer at Lonza Biologics, based in Slough, United Kingdom. Prior to that, Keval was a Microbiologist at Eli Lilly, based in Basingstoke from Jan 2000 to Jan 2001.
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Keval Tanna's current jobs
Keval Tanna's past jobs
Responsible for providing Quality oversight for corporate ERP, logistics and plant asset management systems (inc. SAP, Serialization). Consult on harmonisation, improvement and efficiency of key process, including Change Management, System Lifecycle, Validation, Risk Management, Investigatons and other Quality Systems. Collaborate with key stake holders to ensure continued compliance with regulations and inspection readiness.
Supporting EMEA commercial affiliates in all aspects of computer system compliance. Business partnering with local/regional IS and Quality units and supporting regulatory inspections and inspection readiness program. Global process, program and system deployments. System release approval. Quality System improvement and Change management consultation. Also supported system and process integration with Pfizer.
Oversight of validation/ qualification activities at facility including computer systems compliance, IT infrastructure, GMP utilities & production facility and related manuf/lab equipment. Key involvement in several successful regulatory inspections and global validation/ Quality project deployments. Implemented global R&D Quality Management System/processes and Change Management process lead, as well as vendor & subcontractor audits. Decommissioning of R&D site and set-up of flagship GXP facility in US and Eurasia HQ in UK. Line & contractor management.
Essentially QA for IT. Accountable for validation of all GXP computer hardware and software applications, including ERP system and CDAS. Management of all IT validation projects as well as developing, implementing and maintaining the IT Quality Management infrastructure, ensuring continued compliance with IT standards and regulatory requirements.
Computerised Systems Validation: Responsible for CSV efforts on several projects and upgrade of a manufacturing plant with new technology. Validation documentation generation/execution, qualification of automated equipment, review/testing of control system software code and 21 CFR part 11 compliance. Facilities Validation: Validation of a fermentation based primary production biotech facility. Included cleaning (CIP/SIP) and automation validation.