Mitesh Patel

Background

About Mitesh Patel

21+ years of experience in Pharmaceutical Quality Control (QC), specializing in regulatory compliance, analytical testing, and lab management for oral dosage formulations (tablets, capsules, liquids, dry syrups, sachets). Looking for senior leadership opportunities in pharmaceutical industries. Quality Control Leadership Led daily QC operations for Finished Products, Raw Materials, Stability Samples, and Packaging Materials, ensuring timely sample analysis and data reliability. Strengthened cGMP, cGLP, and regulatory compliance across all QC functions. Regulatory Compliance & Documentation Reviewed and approved Certificates of Analysis, Stability Protocols, Analytical Methods, Instrument Qualifications, and Validation Reports to meet global regulatory standards. Managed regulatory inspections and customer audits (MHRA, EU-GMP, WHO, Health Canada, ANVISA, TGA, etc.), ensuring data integrity. Deviation & Risk Management Investigated Lab Incidents, Deviations, Out of Specification (OOS), Change Controls, Out of Calibration, and Out of Trend results, implementing CAPA strategies to mitigate risks. Ensured thorough root cause analysis and regulatory-compliant documentation. Training & Team Leadership Developed and conducted training programs on cGMP, cGLP, instrument handling (HPLC, Dissolution Test Apparatus, UV-VIS, GC, FTIR, Karl Fischer, etc.), calibration, validation, and compliance requirements. Lab Automation & Instrument Upgradation – Spearheaded the automation of documentation systems and modernized testing instruments, enhancing efficiency and accuracy. Built a skilled and regulatory-ready QC team through hands-on coaching and mentorship. Instrument & Laboratory Management Supervised instrument calibration, preventive maintenance, and AMC management to ensure optimal lab performance. Controlled lab inventory, reagents, and working/reference standard procurement to maintain operational efficiency. Technology Transfer and Reduced testing Led technology transfer of analytical methods across locations and vendors, ensuring seamless integration of new manufacturing processes. Reduced reliance on external contract testing labs by implementing in-house testing for active and excipient raw materials per pharmacopeia standards. Audit Readiness & Compliance Checks Proactively conducted data integrity checks and system health evaluations, ensuring adherence to global regulatory expectations. Provided clear, audit-ready documentation to support compliance in internal and external inspections.