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GMDP-0062

Freelance GMP/GDP Auditor

Disponible

Années d'expérience

GMP - Good Manufacturing Practice

Spécialisation

Inde

Localisation

À propos de cet expert

Have 35+ years of experience in MNC Pharma in areas of Quality Control, Quality Assurance, Microbiology & Green field projects. Since 2018 working as Freelance GMP Auditor & Pharma consultant. Have been audited more than 250 firms manufacturing Sterile dosage forms, Non-sterile dosage forms( OSD, liquids, Capsules, ointments, dusting powder), API, Intermediates, Excipients, packing material, contract laboratories. warehouse & supply chain in India (70%) and abroad (30%)in Europe, South Asia, Africa, Latin America.

Compétences

Expert

Oral solid dosage API Manufacturing Sterile manufacturing

Avancé

Packaging Computer system validation GDP (Good Distribution Practice) Data Integrity GDP Compliance Regulatory inspection support Change Control SOP Writing & Review Internal auditing GMP Auditing Supplier Auditing Process validation CAPA Management Deviation Management IQ/OQ/PQ Validation Equipment qualification Facility qualification

Intermédiaire

Cleaning validation Process Validation Microbiological testing Stability Study Design & Execution Method validation

Certifications

Certified Lead Auditor (IRCA) – ISO 9001:2015 Quality Management System Certified HACCP Auditor Six Sigma Green Belt Approved Microbiologist Certified Lead Auditor (IRCA) – ISO 9001:2015 ISO — Lead Auditor certificate ISO 9001:2015 (2008-02-02)

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