M. Gopi Reddy

Vice President and Head -corporate Quality Compliance and Cqa @SUN PHARMA

Mumbai, MH, IN
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Dec 2022 — Present

Vice President and Head -corporate Quality Compliance and Cqa @SUN PHARMA

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Mumbai, IN

Responsible for design and implementation of Corporate systems and compliance across Sun Pharma sites including contract manufacturing and vendor sites. Responsible to develop SME to ensure anytime audit readiness of all sites for successful regulatory inspections. Responsible to develop and implementation of global quality standards and SOP’s for key systems across all sites.

EDUCATION

1993 — 1995

Nagpur University

M.Pharm,MBA, Pharmaceuticals Chemistry

N/A

Indian Institute of Management Ahmedabad

Leadership developmemt programme, Business, Management, Marketing, and Related Support Services

SKILLS

UvDeviationsStability StudiesPharmaceutical ManufacturingBatch ReleasePharmaceutical IndustrySopDeviation ManagementFdaGlpCapaQuality SystemV&VRegulatory RequirementsSterilizationRegulatory AffairsQuality by DesignEctdGxpEquipment QualificationQuality AuditingAseptic ProcessingPharmaceuticsIch GuidelinesChange ControlComputer System ValidationKarl Fisher21 Cfr Part 11Generic ProgrammingAnalytical Method ValidationClinical MonitoringCleaning ValidationCgmp PracticesDissolutionLyophilizationPharmaceutical ResearchMhraValidationMass SpectrometryHplc

ABOUT M. GOPI REDDY

With over three years as Vice President and Head of Corporate Quality Compliance and CQA at Sun Pharma, I focus on designing and implementing corporate systems and ensuring compliance across global manufacturing and vendor sites. My work is dedicated to fostering a robust framework of global quality standards and standard operating procedures (SOPs) to maintain regulatory adherence and audit readiness for all sites. With extensive experience in quality operations, I have cultivated a strong foundation in ANDA, validation, and mass spectrometry, enabling contributions to regulatory success. My mission is to uphold quality excellence and compliance, driving operational standards that align with Sun Pharma\'s commitment to delivering trusted pharmaceutical products globally.

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M. Gopi Reddy — Vice President and Head -corporate Quality Compliance and Cqa at SUN PHARMA in Mumbai, MH, IN | Unifers