Details
Skills
• Regulatory Audit Management like EU GMP Audit, EU Mock Audit, TFDA, Zimbabwe (MCAZ), PPB (Kenya), Ethiopia (FMHACA), etc.
• Investigation of Deviation, customer complaint and OOS.
• Handling of Change Control
• Management of CAPA
• Handling of Product Recall
• Annual Product Quality Review
• Internal and External Audit Management
• Qualification and Validation of area, equipment and machine
• Cleaning Validation considering the worst case & PDE value.
• Computer system validation
• Quality Risk Management
• Training
• Process Skill: OSD, SVP, LVP, Ophthalmic Eye Drops, Ophthalmic Ointments, ampoule, vial, LVP, etc.
• Dossier Submission
About
Action-and results-oriented pharma professional with almost 16 years of experience working in Pharmaceutical Quality Assurance in EU GMP
approved manufacturing facility. Proficient skill in handling of global GMP audit, new facility establishment, technology transfer and risk-based validation for Oral Solid & Sterile products. Significant knowledge on regulations, guidelines and industry practices (e.g. ICH, CFR 21, PIC/S, GxP, ISPE, PDA etc.) across multiple health authorities (e.g. EU GMP, USFDA, UK MHRA etc.) and ability to guide the team for implementing quality management system. Furthermore, I have proven abilities in training personnel in their respective roles through effective and engaging training programs.
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