Highlights:

Skills:Capillary Electrophoresis,HPLC,ELISA, Computer System Validation, Biopharma Quality Control, IT QA Life Sciences

Computer System Validation Lead 07/2021 - current
Mphasis Ltd, Bangalore, India
Industry: IT Consulting
• Experienced Software Quality Engineer (Life Sciences) with 12+ years in Verification & Validation (V&V), SD(T)LC, Computer System Validation (CSV), and regulatory compliance in the Life Sciences, Biopharma, and Medical Devices industries. Proficient in FDA, EMEA, ISO 13485, and GAMP5 standards, with a strong background in managing end-to-end validation strategies for enterprise systems, medical device NPIs, and laboratory software. Experienced in risk assessments, resource planning, team leadership, and ensuring compliance with GxP and data integrity standards.
• Lead Verification & Validation (V&V) and Computer System Validation (CSV) activities across multiple enterprise-level projects in Laboratory software, IVD, and medical device sectors. • Lead cross-functional teams to ensure seamless execution of validation activities and manage direct communication with clients to deliver projects on time. • Coordinate SDLC activities, ensuring compliance with Agile and Waterfall methodologies for laboratory software and analytical instrument control systems (HPLC, LC-MS, CE-SDS, ICE). Key accomplishments include: • Scientific Software Validation: SD (T) LC: Oversaw validation efforts for analytical instruments (HPLC, LC-MS, CE-SDS, ICE), ensuring they met regulatory standards. Led system troubleshooting, installation, and configuration in client-server architecture environments. • Risk-Based Validation & IT QA: Conducted IT QA risk assessments for validation projects, ensuring robust, risk-mitigated systems. Worked extensively with cross-functional teams to align on risk mitigation strategies and ensure compliance with global regulations. • CSV Leadership & Project Management: Led the validation of enterprise-level systems (MES, LIMS, AWS Cloud, Chromatography Data Systems) across multiple sectors, ensuring compliance with FDA 21 CFR Part 11 and GAMP5. Managed all aspects of the validation lifecycle from URS preparation to IQ/OQ/PQ execution. • Client and Stakeholder Coordination: Maintained initiative-taking communication with clients, ensuring project milestones were met, and requirements were adhered to. Led teams in multiple GxP-compliant environments, ensuring smooth execution of tasks across internal and external stakeholders.--
Scientist 01/2020 - current
Baxter Global Research Center, Banglore, Karnataka India
Industry: Pharmaceauticals
QC Bioanalytical Operations
Responsibilities include new product development activities, device compatibility studies, analytical method development, method validation and stability studies.--
Scientist 11/2017 - 08/2019
PPD Development Ireland Ltd, Athlone, Leinster Ireland
Industry: GMP Contract Testing Laboratory
QC Biologics Analytical Testing Operations
Responsibilities include performing stability, batch release testing of biomolecules by strictly adhering to GMP practices.--

Vinayaka Missions University 05/2008 - 05/2012
Channai, , India
Degree: Bachelor's Degree
Major:Biotechnology
Relevant Modules: C, C++, Electronics Engineering, Analytical Instrumentation, Biotechnology, Biochemistry, Immunology, Molecular Biology, Bioprocess Engineering, Quality by Design (QBD) Principles