Vinayak Hegde

Quality Assurance professional with 17+ years of experience in Pharmaceutical Quality Systems, QA Governance, Regulatory Compliance, Audit Readiness, CAPA Management, Quality Management Systems (QMS), Data Integrity, Digital Quality and Validation within regulated GMP environments. Strong expertise in GAMP 5, 21 CFR Part 11, EU Annex 11, SDLC (Software Development Life Cycle), Computer System Assurance (CSA), ERP (Enterprise resource planning) Validation, eQMS, ALCOA+, Electronic Records & Electronic Signatures, Vendor Qualification, Validation Master Plans (VMP), FAT/SAT, Qualification and Regulatory Inspection Management. Proven expertise in driving quality initiatives, tracking quality metrics, leading cross-functional compliance programs, managing global regulatory inspections and strengthening inspection readiness across manufacturing and quality operations.

Experienced in stakeholder management, quality systems, risk-based compliance, SOP and continuous improvement initiatives aligned with cGMP and global regulatory expectations.

Manager – Quality Assurance at Micro Labs Ltd. (2012-09 – Present)

• Lead cross-functional QA and validation projects ensuring compliance with global regulatory standards, GMP requirements and Corporate Quality Assurance (CQA) objectives.
• Managed end-to-end computerized system validation activities for GMP computerized systems aligned with GAMP5, 21 CFR Part 11, Annex 11 and CSA methodologies.
• Implemented digital quality and validation systems reducing documentation review turnaround time by 30% and improving audit traceability and compliance monitoring.
• Conducted GAP assessments and remediation activities resulting in successful regulatory inspection outcomes and enhanced inspection readiness across operations.
• Supported multiple global regulatory inspections including USFDA, MHRA, WHO, TGA, Health Canada, Germany, Russia, Ukraine and customer audits with no critical observations.
• Validation & Qualification: IQ, OQ, PQ, FAT/SAT, HVAC Qualification, Utility Qualification, IT Infrastructure Qualification and Temperature Mapping
• Quality Systems: CAPA, Deviations, Change Control, Risk Assessment, Root Cause Analysis, and Quality Governance.
• Monitored quality system trends including deviations, CAPA closure timelines, change controls and audit commitments.
• Compliance & Validation: SDLC Validation, Risk-Based Validation, CSA., Vendor Assessment, Supplier Quality Management
• Data Integrity & IT Compliance: Audit Trail Review, Backup & Restore, Disaster Recovery, Business Continuity, Electronic Records Management, Cybersecurity Awareness
• Laboratory Instruments: HPLC, GC, UV, FTIR
• Documentation & Governance: Validation Protocols, VMP, QMS Documentation, Regulatory Inspection Management
• Led validation lifecycle activities including SDLC validation, risk assessments, software categorization, periodic review and validation processes.
• Oversaw qualification activities including IQ/OQ/PQ, HVAC qualification, utility qualification, FAT/SAT execution, compressed gas systems, area qualification and temperature mapping.
• Managed review and approval of Validation Master Plans (VMP), qualification protocols, SOPs, CAPAs, deviations, change controls and risk assessment documentation.
• Conducted GMP, Data Integrity and CSV training programs for 150+ employees across QA, QC, Engineering, Manufacturing and IT departments.
• Participated in internal audits and governance meetings to drive continuous improvement and regulatory compliance across sites.
• Strengthened data integrity practices through audit trail review, backup verification, disaster recovery checks, electronic records management and business continuity compliance.
• Managed vendor qualification and supplier assessment activities ensuring compliance with regulatory and validation requirements.
• Reviewed and monitored quality metrics, compliance KPIs, CAPA effectiveness and audit observations for management review and governance discussions.
• Supported Corporate Quality Assurance (CQA) activities including inspection readiness reviews, escalation management and quality compliance monitoring.
• Collaborated with stakeholders across QA, QC, Engineering, Manufacturing, IT and external vendors for successful project coordination, Quality improvement programs and compliance execution.
• Contributed to development and revision of site as well as corporate SOPs and compliance guidelines
• Supported validation and IT infrastructure qualification activities within regulated GMP environments.
• Drove digital transformation initiatives improving operational efficiency, validation traceability and compliance governance across quality systems.
• Enhanced quality and compliance culture through leadership, mentoring and continuous improvement initiatives.

Executive – Quality Control at Lupin Ltd. (2008-01 – 2012-08)

• Managed QC laboratory operations involving analysis of raw materials, finished products and packaging materials in compliance with cGMP requirements.
• Performed analytical testing using HPLC, GC, UV and FTIR instruments as per pharmacopeial and regulatory standards.
• Supported instrument qualification, IT compliance activities, laboratory documentation management and GMP computerized systems monitoring.
• Investigated OOS, OOT and laboratory incidents while supporting CAPA implementation and root cause analysis activities.
• Maintained release documentation, SAP master data, COA generation and electronic records management with strong focus on data integrity compliance.
• Assisted in audit readiness programs and supported regulatory inspections and compliance reviews.
• Contributed to laboratory process improvements, validation support activities and quality system enhancements.

MSc in Chemistry – Kuvempu University

BSc in Biochemistry – Mangalore University