03/15/2025 updated
100 % available
GMP Quality Auditor , Experienced in Analytical Development and Quality Operations
Dombivali East, India
Worldwide
Master of Science in Organic ChemistryChromatographyAnalytical ChemistryScientific InstrumentsAuditingRaw MaterialsISO 9000Good Manufacturing PracticesQuality AuditingComplianceData IntegrityInstrumentationMedication AdministrationOrganic ChemistryQuality ManagementDissolution
Quality Auditing
Global Qualified Quality Auditor for Third party sites, raw materials, and regulatory compliance. Ensures quality and compliance standards are met across operational units and affiliates.
Analytical Development
Expertise in analytical method development, validation, and transfer. Oversees method development, validation protocols, and reports for pharmaceutical products.
Regulatory Compliance
Proficient in Food & Drug Administration Approval processes, chemical analysis, and instrumentation. Ensures adherence to regulatory guidelines and quality standards.
GMP and Data Integrity
Knowledge of Good Manufacturing Practices (GMP) and data integrity principles. Implements and maintains GMP compliance in pharmaceutical operations.
Risk Assessment
Conducts supplier quality risk assessments and implements comprehensive risk assessment models. Develops and implements supplier risk assessment strategies.
Quality Management Systems
Proficiency in Quality Management Systems, including ISO 9001:2015. Implements and audits quality management processes across pharmaceutical operations.
Analytical Techniques
Expertise in various analytical techniques including HPLC, GC, and dissolution testing. Maintains and troubleshoots analytical instruments and develops analytical methods.
Global Qualified Quality Auditor for Third party sites, raw materials, and regulatory compliance. Ensures quality and compliance standards are met across operational units and affiliates.
Analytical Development
Expertise in analytical method development, validation, and transfer. Oversees method development, validation protocols, and reports for pharmaceutical products.
Regulatory Compliance
Proficient in Food & Drug Administration Approval processes, chemical analysis, and instrumentation. Ensures adherence to regulatory guidelines and quality standards.
GMP and Data Integrity
Knowledge of Good Manufacturing Practices (GMP) and data integrity principles. Implements and maintains GMP compliance in pharmaceutical operations.
Risk Assessment
Conducts supplier quality risk assessments and implements comprehensive risk assessment models. Develops and implements supplier risk assessment strategies.
Quality Management Systems
Proficiency in Quality Management Systems, including ISO 9001:2015. Implements and audits quality management processes across pharmaceutical operations.
Analytical Techniques
Expertise in various analytical techniques including HPLC, GC, and dissolution testing. Maintains and troubleshoots analytical instruments and develops analytical methods.
Experience
Professional experience10+ years
Freelancer since2024
Languages
EnglishFluent
Project history
Providing consultancy services in GXP (Good Practices) areas.
Managed quality-related activities at external suppliers, conducted supplier audits, and ensured regulatory compliance.
Led analytical and quality operations team, managed outsourced testing, and ensured regulatory compliance.
Certificates
ISO 9001:2015 Lead Auditor for Quality Management Systems
IRCA and CQI2021
Global Quality Auditor
Sanofi Global Quality Team2016