Durga Phalke Mane

About Durga Phalke Mane

As General Manager of Quality Compliance at Zydus Group, I oversee global quality compliance for clinical trials of new chemical entities and biosimilars across Phases I-IV. My work is centered on developing, implementing, and managing quality management systems for Zydus Therapeutics and Zydus Life Sciences, ensuring adherence to ICH GCP guidelines, SOPs, and regulatory standards. With extensive experience in quality assurance and clinical operations, I contribute to planning and managing quality programs, conducting compliance reviews, and overseeing vendor evaluations to uphold robust clinical trial standards. My focus is on enabling excellence in quality compliance while supporting innovation in the pharmaceutical and life sciences sector.

Experience

1. General Manager Quality Compliance (Global)

   Zydus Group

   Apr 2022 — Present · IN

   Managing Quality Compliance activities of Zydus Therapeutics global Clinical trials of New Chemical entity and Biosimilars in Phase I, II and phase Quality Compliance team responsible for development, implementation and management quality management systems for quality compliance function of Zydus Therapeutics Ltd and Zydus Life Science Responsible for planning and managing Quality program of global clinical Trials of Zydus Therapeutics Phase I, Phase II, Phase and Phase IVConduct Quality compliance review site visits at Investigators site in order to check whether Clinical trial is conducted as per the Clinical study protocol, ICH GCP, SOPs and applicable regulatory requirementsResponsible to oversee the evaluation and qualification of vendors across geographies comprising of Clinical Data Management, Clinical Laboratory, Medical Writing and Regulatory submissionResponsible to identify the need and oversee the creation review and approval of Quality Policy, standard operating procedures, standard work instructions and allied quality documentsInvolved in review and approval of clinical trial specific documents like Protocol, Investigators Brochure, Project Management Plan, Clinical Monitoring Plan, Quality Control Plan, trial specific templates/forms, DSUR, Clinical study Reports

Education

• Dr. Babasaheb Ambedkar Technological University

  Bachelor's Degree

• Y.B.Chavan College of Pharmacy, Dr.Babasaheb Ambedkar Marathwada University

  B.Pharm, Pharmacy subjecs

  1993 — 1997

• Shri Guru Tegh Bahadur school Aurangabad

  SSC, SSC Board

  1981 — 1991

• Sikkim Manipal University

  Master of Business Administration (MBA), Operations Management

  2010 — 2012

• C.U.Shah college of pharmacy,S.N.D.T University

  M.Pharm, Pharmacy, Quality Assurance

  1998 — 2001

• C. U. SHAH UNIVERSITY

  Master's Degree, Quality Assurance

Skills

• Validation
• CRO
• Corrective and Preventive Action (Capa)
• CRO Management
• Regulatory Submissions
• Pharmacovigilance
• Gmp
• Good Laboratory Practice (Glp)
• Inspection
• Gcp
• 21 Cfr Part 11
• U.s. Food and Drug Administration (Fda)
• Standard Operating Procedure (Sop)
• Verification and Validation (V&V)
• Gxp
• Quality Auditing
• Regulatory Affairs
• Quality System
• Ich-Gcp
• V&V
• Glp
• Clinical Trials
• Pharmaceutics
• Quality by Design
• Microbiology
• Pharmaceutical Industry
• Sop
• Fda
• Auditing
• Clinical Research
• U.s. Title 21 Cfr Part 11 Regulation
• Capa
• Good Clinical Practice (Gcp)
• Regulatory Requirements
• Quality Assurance