02/28/2025 updated
100 % available
Senior Quality Assurance Professional in Pharmaceutical Industry
Modinagar, India
Only remote
Master of Pharmacy (Pharmaceutics) from LIMT, Dr. A.P.J. Abdul Kalam University (GBTU), LucknowAuditingAudit PlanningComplianceManufacturingOutsourcingPharmaceuticalsQuality ManagementTechnical DocumentationIso/iecPackaging and Processing DutiesPharmaceutical Production
Quality Assurance and Compliance
Extensive experience in Corporate Quality compliance, site compliance, outsourcing, and regulatory compliance in the pharmaceutical industry.
Regulatory Inspections
Participation in regulatory inspections from ANVISA, UKRAINE, WHO-GMP, and several ROW regulatory authorities.
Quality Management Systems
Expertise in Quality Management System, Facility Qualification, API vendor audit, Manufacturing site audit, and Internal audit/Compliance.
Pharmaceutical Manufacturing
Experience with multinational and domestic manufacturing sites involved in producing Tablet, Capsule, Soft Gelatin, Dry syrup, Oral solution, Injectable, Ointment, Cream, and Gel.
Audit Planning and Execution
Responsible for audit planning of manufacturing sites, third-party audits, and preparation of audit agendas and reports.
Technical Documentation
Preparation and review of technical agreements, SOPs, quality policies, and analytical documents for manufacturing and packing processes.
Regulatory Compliance
Expertise in ISO/IEC standards, including 17025:2017, 17043:2010, and 17034:2016 for audit compliance reports.
Extensive experience in Corporate Quality compliance, site compliance, outsourcing, and regulatory compliance in the pharmaceutical industry.
Regulatory Inspections
Participation in regulatory inspections from ANVISA, UKRAINE, WHO-GMP, and several ROW regulatory authorities.
Quality Management Systems
Expertise in Quality Management System, Facility Qualification, API vendor audit, Manufacturing site audit, and Internal audit/Compliance.
Pharmaceutical Manufacturing
Experience with multinational and domestic manufacturing sites involved in producing Tablet, Capsule, Soft Gelatin, Dry syrup, Oral solution, Injectable, Ointment, Cream, and Gel.
Audit Planning and Execution
Responsible for audit planning of manufacturing sites, third-party audits, and preparation of audit agendas and reports.
Technical Documentation
Preparation and review of technical agreements, SOPs, quality policies, and analytical documents for manufacturing and packing processes.
Regulatory Compliance
Expertise in ISO/IEC standards, including 17025:2017, 17043:2010, and 17034:2016 for audit compliance reports.
Languages
EnglishFluent
Project history
Coordinating with technical team for compliance of 40 manufacturing sites as lead auditor. Responsible for Technical Agreement of service provider, New Product Introduction, Quality Management System, and Outsourcing SOP.
Handled Quality Management System, Review of Change control, Review of Deviation, CAPA, Handling of Market complaints. Prepared Audit compliance Reports for ISO standards.
Worked as an executive in Regulatory Audits, handling ANVISA-Brazil, WHO and Internal audits.