Strategic leader with broad experience managing quality functions with multi skill experience. Had hands on experience in Audits & Compliance. Had experience in working with global customers & suppliers and adopted global ways of working.
Provide leadership, direction and coordinate all quality assurance activities in accordance with the policies, goals and objectives of Alembic.
Oversee and direct the quality systems to ensure business, customers and regulatory requirements.
Manged regulatory inspections like USFDA, EU GMP, ANVISA etc. and formulated responses.
Successful record of building teams, managing organizational change and remediating compliance risks.
Handling a team of more than 250 people in quality assurance.
Handling of regulatory audits and formulated responses Strong hold on cGMP systems Failure investigations Quick resolution / decisions for quality issues People management & handling a team of more than 250 people
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