Experience

Genpact Digital

• IT Services and IT Consulting
• 100 - 200 Employee

• Quality and Compliance Lead- Process Excellence

  • Jan 2020 - Present

  Design, manage and maintain all Quality Assurance practices, standards, methodologies, and metrics based on standard industry regulations and customer requirements. Build and provide Risk based strategic direction to the leadership and cross functional teams to build a best in class capability to ensure AI driven IT product is fit for purpose, consistent and meets clients and industry requirements. Responsible to efficiently lead a motivated team and coordinate the activities to meet the product goals and quality standards. Show less



Infosys Consulting

• India
• Business Consulting and Services
• 700 & Above Employee

• Principal Consultant- Lifescience- ITGRC

  • Jun 2018 - Feb 2020

   Risk Management (Identification, Analysis and Mitigation) for a major Pharma company.  Driving control maturity assessment and mitigate and remediation of Process control gaps and information / IT risks  IT audits as external auditor, control / self-assessments, control testing and third party assessments  Mentoring and Guiding Computer system validation team for GxP systems  Establishing KPI’s for Risk Management team and Validation activities  Risk Management (Identification, Analysis and Mitigation) for a major Pharma company.  Driving control maturity assessment and mitigate and remediation of Process control gaps and information / IT risks  IT audits as external auditor, control / self-assessments, control testing and third party assessments  Mentoring and Guiding Computer system validation team for GxP systems  Establishing KPI’s for Risk Management team and Validation activities



IQVIA Asia Pacific

• Singapore
• Hospitals and Health Care
• 700 & Above Employee

• Manager- QA, System Compliance Office

  • May 2016 - Jun 2018

   Quality representative for Cardiac systems and connect devices (ECG, Actigraphy, CGM, BPM)  Lead Internal audits and third party assessments for Computer System Validation (CSV) of IT Systems  Strategic and Tactical guidance to IT program teams and Process Owners for Validating Computer Systems, Cloud Infrastructure with Robust quality process engineering techniques  Host Regulatory Inspectors and respond to regulatory bodies for Queries during inspections.  Act as a Quality Management Representative during external sponsor audits.  Continuously monitor Quality processes and enforce governance across processes.  Train, Coach and Mentor Validation Managers & cross functional team  Develop Quality Metrics’ and re-engineer Quality processes for continuous Quality Improvement Show less



GE HealthCare

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Validation Manager

  • Jul 2013 - Apr 2016

   Managed the End to End Validation activities for 9 million $ GEHC Quality IT systems  GxP, Risk (Risk based approach), Part11 (ERES) assessment(s)for the IT Systems  Managing Team budget Finance and liquidations for the Validation CoE (VMCoE)  Managing IT Validation On Demand (ITVoD) Vendor team.  Representing Regulatory audit for GEHC manufacturing sites from IT Validation perspective  Maintaining the Validated state of the system, post GO-Live  Deviation management, Incident Management, change management and Retirement  Performing Vendor audit and supporting engineering team during their regulatory audits.  Implemented simplification in Validation process in business projects Show less



ArisGlobal

• United States
• Software Development
• 700 & Above Employee

• Compliance Lead

  • Dec 2011 - Jun 2013

  CSV Complaince for end to end Implementation projects with the Risk based approach. Supplier audit, Vendor audit management, change management and ensuring SAS compliance. Process improvements for the SAS model (Pre-validation approach) CSV Complaince for end to end Implementation projects with the Risk based approach. Supplier audit, Vendor audit management, change management and ensuring SAS compliance. Process improvements for the SAS model (Pre-validation approach)



Patni Computer Services

• Healthcare Consultant- Lifesciences

  • Nov 2010 - Nov 2011

  Regulatory complaince for Lifescience and Health care industries in 21 CFR Part 11,GxP Assessments,Project Management,Summarizing Validation Plan,Validation reports,SRS Review,CSV Testing. Regulatory complaince for Lifescience and Health care industries in 21 CFR Part 11,GxP Assessments,Project Management,Summarizing Validation Plan,Validation reports,SRS Review,CSV Testing.



Honeywell

• United States
• Appliances, Electrical, and Electronics Manufacturing
• 700 & Above Employee

• Team lead

  • Mar 2008 - Jun 2010

  Qualification Excellence and Solutions Demonstrated skills as SME for Honeywell Process industry solutions domain (Pharma) Reviewed and clarified requirements, use cases and functional specifications Provided domain/functional inputs for testing, development, usability, and Research & Technology teams to analyze and resolve the gaps and to initiate new products Verified and validated Web and Desktop applications Involved in two products, end to end SDLC and successfully delivered Sound domain experience in production, inventory, quality Procedures such as CGMP specifications and 21 CFR Part 11 Extensive Experience with Validation ,Requirements, Functional and Integrated testing for Regulated Industries (FDA,CGMP,GAMP) Experienced in Interface Testing of MES application with DCS, PHD, TPB Applications using OPC connect. Prepared project estimation, test design, test plan and approach documents Managed new and maintenance products quality and schedule Executed and implemented process improvement KAIZENs Led productivity saving through automation and reuse Conducting meetings and reviews with testing, development, quality audit teams and customers Show less



Cipla

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Management Staff

  • May 2002 - Feb 2008

  Cipla is one of the most paramount pharmaceutical companies of India. Cipla, Bangalore unit complies for CGMP aspects and certified by USFDA, TGA, and WHO Organizations. Production planning by quarterly and control by weekly basis ,cycle time calculation of the products, department inventory management Worked in shop floors and Maintained Process Parameters to meet the data as per the Process data sheets. Annual product review, change control, investigation, deviation, validation. Reviewing the equipment occupancy and costing of the new products End user in SCADA/PLC operation in shop floors Actively Participated in 3 USFDA, 2 TGA and 1 WHO audits Confirmed 50 days earlier from the date of confirmation for playing an Active role in USFDA 2002 Trained in GMP by Norman Franklin (Cipla Consultant) Carried out Process and Equipment Validation in Oncology Block. Indenting and ensuring the availability of the raw material & facility based on the planning. Show less