Senthilkumar Pandurengan

Background

About Senthilkumar Pandurengan

Ambitious Senior Test / CSV / Compliance Lead, having 10+ years of experience in the field of Quality Engineering and Assurance and Overall 16+ years of IT experience. 9+ years of Experience including Onshore in Life Science, Pharmaceutical domain as Quality & Compliance Consultant, Computer System Validation Lead and SME for Life Sciences and Pharma industry. Experience in Computer System Validation, GAMP 5, 21 CFR Part 11, Annex 11 compliant systems; GxP Risk Assessment, Validation Plan, Risk Based Validation, IQ, OQ, PQ Validation Summary Report, Production release testing, Hyper-care support after production release, Change Management Experience in managing program, project, timelines, mitigations, resourcing, demand, customer and testing from Software Validation perspective Experience in running large programs across various technologies, in various methodologies like Waterfall & Agile methodology Discussion and finalization of Validation strategy/Test strategy Plan with Business Owner, Application Owner and Quality personnel. End to End authoring and review of SDLC deliverables including Validation / Test Plans, Validation / Test Summary Reports, RTM, Validation Protocol (IQ, OQ, PQ) design and execution and so on. Handled many GxP Projects with active participation from beginning of the project till closure and in attending all meetings directly with Client PM, IT System Owner / SMEs, IT Quality team without any onshore co-ordination in UK Shift timings. Review Life Cycle documents in line with process SOPs, process controls, ensure they are available, complete and consistent. Worked with, compliance lead, Global process owners to understand requirements, ensure these compliance requirements are met & adhered to regulatory & process control. Performed diverse roles based on the needs of the projects and delivered the services at the highest quality standards and met the expectations of the client. Prepared Guideline Decks, Checklist, Job aids based on the Client Process SOPs and GDP guidelines and mentored the team who are newly onboarded before deploying them in Client GxP Projects. Formed an internal Quality Review team with Champions to review all the GxP Deliverables before delivering the same to Client IT Quality team which helped them to improved First time Right Quality. A strong team player with good analytical and excellent communication skills with the leadership abilities to direct, conduct, motivate and evaluate teams. Exposure in RFPs and involved in multiple management activities