Head of Quality Functions, 30 years exp.
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Work experience and technical skills on Oral solid - Tablet & Capsules, Injectable, Biologics dosage Formulations and API with domestic & export markets.
Core expertise in Sterile and non-sterile, QMS tools, Instrumentation & Part11 software qualifications, Audit and Compliance.
Successfully handled Regulatory audits (USFDA, EMA/MHRA, WHO, PMDA, KFDA, ANVISA etc.), Customer audits, Vendor audits and GMP remediation plan with effective CAPA implementation.
Proven experience of managing & building core SME teams, Corporate Quality functions, CDMO & engagement for customer requirements with compliance and on time productivity delivery.
