11/29/2025 updated
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Senior Quality Assurance & CSV Professional in Pharmaceutical Industry
Dombivli (East), Thane, India
Only remote
Master in Business Administration, Marketing & International BusinessTitle 21 of the Code of Federal RegulationsAgile MethodologyArtificial IntelligenceAnnexationAuditingComplianceComputer SecurityInformation SystemsISO/IEC 27001Project ManagementMedicines and Healthcare Products Regulatory Agency (MHRA) GuidesPharmaceuticalsQuality ManagementRegulatory RequirementsRisk Analysis
Quality Management Systems
Certified Quality Auditor for QMS approved by RABQSA & IRCA with expertise in regulatory compliance requirements and quality assurance processes
Computer System Validation
Expertise in CSV Compliance according to GAMP 5, 21 CFR PARTS 11, EU ANNEX 11, PICS, UK-MHRA with software vendor assessment capabilities
SAP Systems Implementation
Software Validation expertise for multiple SAP S4 Hana projects and SAP modules implementation with regulatory compliance focus
Information Security Auditing
Certified Information Security Auditor for ISO 27001:2015 by PECB, Canada
Emerging Technologies
Sound knowledge about Artificial Intelligence, Internet of Things, Agile CSV, Data lake validation, Block chain and cloud-based implementation
Risk Assessment and Management
Expertise in GAMP 5 requirements, risk-based approach, and various assessment methodologies including GxP Assessment and Functional Risk Assessment
Regulatory Compliance
Expertise in pharmaceutical regulatory requirements including 21 CFR PARTS 11, EU ANNEXURE 11, GAMP 5, and international regulatory norms
Project Management
Experience in leading medium-sized engagements, managing staffing, budgets, resources and risks for assigned streams
Certified Quality Auditor for QMS approved by RABQSA & IRCA with expertise in regulatory compliance requirements and quality assurance processes
Computer System Validation
Expertise in CSV Compliance according to GAMP 5, 21 CFR PARTS 11, EU ANNEX 11, PICS, UK-MHRA with software vendor assessment capabilities
SAP Systems Implementation
Software Validation expertise for multiple SAP S4 Hana projects and SAP modules implementation with regulatory compliance focus
Information Security Auditing
Certified Information Security Auditor for ISO 27001:2015 by PECB, Canada
Emerging Technologies
Sound knowledge about Artificial Intelligence, Internet of Things, Agile CSV, Data lake validation, Block chain and cloud-based implementation
Risk Assessment and Management
Expertise in GAMP 5 requirements, risk-based approach, and various assessment methodologies including GxP Assessment and Functional Risk Assessment
Regulatory Compliance
Expertise in pharmaceutical regulatory requirements including 21 CFR PARTS 11, EU ANNEXURE 11, GAMP 5, and international regulatory norms
Project Management
Experience in leading medium-sized engagements, managing staffing, budgets, resources and risks for assigned streams
Languages
EnglishNative speaker
Project history
Working as a Software Validation expertise for multiple SAP S4 Hana projects, advising clients conceptually, managerially and solution oriented. Leading and managing medium-sized engagements or streams in large complex engagements.
Working as a Project Quality Manager for US MNC dealing in medical devices, handling various GxP & Non-GxP Projects with expertise in team handling and quality culture development.
Worked as Project Lead with Indian MNC providing consulting regarding enterprise software GxP projects implementation and validation strategies for enterprise Apps.