10/28/2025 updated
100 % available
Pharmaceutical GMP & Data Integrity Auditor |
Ahmedabad, India
Worldwide
M.S./M.Sc. (Science)About me
I am a seasoned pharmaceutical professional with over 14 years of experience in GMP compliance, quality assurance, and regulatory audits. I specialize in conducting independent GMP audits for pharmaceutical ensuring alignment with global standards including WHO-GMP, USFDA, EMA, and PIC/S.
Title 21 of the Code of Federal RegulationsResearchAuditingBusiness EfficiencyBusiness Process ImprovementStrategic ManagementGood Manufacturing PracticesCorrective and Preventive Action (CAPA)ComplianceData IntegrityEnvironmental MonitoringMaintenanceManufacturingMicrobiologyQuality Management
GMP & Compliance Auditing
Expertise in pharmaceutical quality and compliance with 14 years of experience across sterile and non-sterile product environments, conducting self-inspections, data reliability audits, and compliance assessments
Data Integrity & Risk Management
Specialized knowledge in regulatory compliance ensuring 21 CFR Part 11 adherence to maintain operational transparency and managing deviations, CAPAs, OOS, OOT, market complaints
Training & Workforce Development
Strategic leadership in developing and executing CGMP training programs, ensuring regulatory compliance and enhancing workforce competency with proven track record of training 200+ personnel
Quality Assurance & Regulatory Compliance
Comprehensive understanding of pharmaceutical quality standards and regulatory requirements across manufacturing, quality, IT, and engineering functions
Audit & Inspection Readiness
Strong track record in investigation and audit readiness, managing technical training documentation to ensure site-wide audit preparedness
Process Improvement & Root Cause Analysis
Analytical skills in identifying compliance gaps and implementing corrective and preventive action plans resulting in significant improvements
Cross-functional Collaboration
Effective collaboration with production, quality and corporate teams to drive compliance excellence, mitigate risks, and enhance operational efficiency
Environmental Monitoring & Laboratory Operations
Experience in managing microbiology-related activities, laboratory operations, instrument maintenance, and environmental monitoring trends
Expertise in pharmaceutical quality and compliance with 14 years of experience across sterile and non-sterile product environments, conducting self-inspections, data reliability audits, and compliance assessments
Data Integrity & Risk Management
Specialized knowledge in regulatory compliance ensuring 21 CFR Part 11 adherence to maintain operational transparency and managing deviations, CAPAs, OOS, OOT, market complaints
Training & Workforce Development
Strategic leadership in developing and executing CGMP training programs, ensuring regulatory compliance and enhancing workforce competency with proven track record of training 200+ personnel
Quality Assurance & Regulatory Compliance
Comprehensive understanding of pharmaceutical quality standards and regulatory requirements across manufacturing, quality, IT, and engineering functions
Audit & Inspection Readiness
Strong track record in investigation and audit readiness, managing technical training documentation to ensure site-wide audit preparedness
Process Improvement & Root Cause Analysis
Analytical skills in identifying compliance gaps and implementing corrective and preventive action plans resulting in significant improvements
Cross-functional Collaboration
Effective collaboration with production, quality and corporate teams to drive compliance excellence, mitigate risks, and enhance operational efficiency
Environmental Monitoring & Laboratory Operations
Experience in managing microbiology-related activities, laboratory operations, instrument maintenance, and environmental monitoring trends
Languages
EnglishNative speaker
Project history
Conducting CGMP and on-job training for employees, designing training plans and modules, monitoring compliance with GMP regulations, managing technical training documentation, and facilitating end-to-end training activities
Delivered training on data integrity, conducted role-based training in microbiology labs, developed monthly inspection plans, reported data integrity breaches, performed risk assessments, and designed GMP training programs for 200+ personnel
Quality control operations and compliance activities