Faraz Ansari
Validation Lead @Tata Consultancy Services
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WORK HISTORY
Validation Lead @Tata Consultancy Services
DE
Manage a team of 15+ Validation Consultants• End-to-end ownership of a diverse portfolio of systems – GAMP 3/4/5, Clinical/ Regulatory/ Quality/ Safety/ Animal Health systems, GxP/ non-GxP systems, Business/ IT systems, COTS/ in-house systems, CTMS/ eDMS/ TMF/ EDC/ Business Intelligence tools, locally hosed/ cloud hosted (SaaS/ PaaS/ IaaS)/ multi-tenant systems• Responsible for the overall system validation and maintenance as per Client SOPs, which includes Compliance assessment, cloud assessment, URS/ FRS/ CS/ Risk Assessment review, Validation Plans, Test Plans, IQ/ OQ/ PQ Plan & Reports, Validation Summary Reports, Change Control Management, Periodic Reviews, CAPA management and audit readiness• Perform various testing such as IQ/OQ/PQ, configuration, automated, database, exploratory, sanity, smoke, performance, data migration, Interface, and reports testing • Conduct workshops on Computer System Validation for the Team• Support and guide the team towards effective system validation activities• Consult clients on validation regulations (SOPs, GxP guidelines, Part 11, ALCOA+, sponsor & vendor obligations, etc.), complex validation strategies, validation of CI/ CD implementation projects, agile projects, etc.• Liaise between business, IT, and vendor teams to ensure correct implementation of requirements• Defended the systems during internal audits and health authority inspections
EDUCATION
SRMCEM, LUCKNOW
Engineer's Degree, Electrical and Electronics Engineering
La Martiniere College, Lucknow
High School, English, Hindi, Science, Mathematics, Social Studies, Computer Science
La Martiniere College, Lucknow
Intermediate, English, Physics, Chemistry, Mathematics, Computer Science
SKILLS
ABOUT FARAZ ANSARI
Several years of experience in consulting Pharma companies in areas of Computer Systems Validation, Computer Systems implementation/ Maintenance/ Change Management as per GxP guidelines, 21 CFR Part 11, audit/ inspections support, Business Process Modelling and Clinical Trial processes. Experience in handling a diverse portfolio of systems – GAMP 3/4/5, Clinical/ Regulatory/ Quality/ Safety/ Animal Health systems, GxP/ non-GxP systems, Business/ IT systems, COTS/ in-house systems, CTMS/ eDMS/ TMF/ EDC/ Business Intelligence tools, locally hosed/ cloud hosted (SaaS/ PaaS/ IaaS)/ multi-tenant systems.Experience of managing overall system validation and maintenance, which includes Compliance assessment, URS/ FRS/ CS/ Risk Assessment review, Validation Plans, Test Plans, IQ/ OQ/ PQ Plan & Reports, Validation Summary Reports, Change Control Management, Periodic Reviews, CAPA management and audit readiness.Process consulting experience in Trial Management areas such as vendor management process, management of fully/partially outsourced trials, processes for different trial types (interventional/ non-interventional, IIS, Compassionate use/ expanded access trials).
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