Suresh P Email & Phone Number

• Senior QA Manager with 17+ years of diversified experience in Project & quality management, Computer system Validation, Quality assurance, Quality systems Auditing and Software development Lifecycle (SDLC)• Possess extensive expertise in managing large, complex projects with cross-functional teams in a distributed environment which involves Agile, Mobile Testing, SharePoint testing, DW/ETL, Performance and Automation testing projects• Extensive experience in Life sciences/ Pharmaceutical industry’s concepts of GAMP 5, 21 CFR part 11, Annex 11 compliant systems, GxP Assessment, Validation plan, Risk management plan, Risk Based Validation testing, IQ, OQ, PQ, Validation/ Test Summary report, Production release testing and Hyper-care support after production release and change management• Has strong knowledge about the Quality systems and their implementations & controls, like Change and Release management, Audit/ Quality reviews, Deviation/ Incident Management, CAPA etc. Have expertise and hands on experience with Computer System Validation & Infrastructure Qualification with Capabilities like strict adherence to CSV guidelines and Regulatory requirements during project delivery, including ensuring Good Documentation Practices, overall responsibility for compliance to GxP related standards, test report creation and review, Risk management, project delivery and maintenance of quality systems. • Experience in assisting Audit preparation for Third-Party External and Internal Audits• Own bottom-up responsibility, right from scoping to project completion, ensuring on-time delivery without compromising on quality.• Very good experience in Operations management like Revenue forecasting, Budgeting, Margin growth analysis etc.• Experience in building various testing Request for proposal (RFP) deals of different value and sizes