Experience

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  Vasudha Pharma Chem. Ltd.

  • Vishakhapatnam , Hyderabad

  • Vice president - Quality and compliance ( QA &QC).

    • Jun 2018 - Jan 2023
    • Vishakhapatnam , Hyderabad

    On 15 June 2018 Joined Vasudha Pharma chem Ltd and worked as Vice president of Quality and Compliance ( QA & QC ) for all Vasudha units. Worked from Visakhapatnam Unit-II, the Parawada industrial area.Last designation: Vice president - Quality & Compliance.Successfully faced Russian Regulatory audit from 03.12.2018 to 04.1.2018 at Unit –I(Auditors : Lead auditor Mr W.V.RYBAKOV and inspectors Mrs TV PITOMTSEVA, Mr R.A.BONDAR)Successfully faced PMDA( Japan regulatory audit ) from 17.12.2019 to 20.12.2019 at Unit – I ( Lead Auditor: Mr. KATSUHIKA MISHIMA, second auditor: Mr. KENJI HAYAMIZU ) for the product: Donepezil.Faced EDQM audit at Unit -1, June 2021.Successfully faced China Regulatory audit from 09.12.2018 to 13.12.2018 at Unit – II (Auditors: Mr. LEE YAWU, Mr. ZHANG HUI, Mr. YAN RUOXI ).Faced KFDA audit at Unit - III, May 2019 (Auditors: GMP inspector: PARK CHAN WOONG and Deputy Director: KIM EUN-KYUNG ).Successfully faced USFDA audit without 483 from 28.10.2019 to 01.11.2019 at Unit – III ( Auditor: Mr. Gam Zamil ).Successfully faced EDQM audit at Vasudha pharma chem Ltd Unit -1 Hyderabad from 21 to 25 th June 2021(Lead auditor: Dr. SOTIRIOUS PARACHOS and Inspector: Dr. ANNA TARZIA).Actively involved and resolved many quality-related issues by identifying root causes, implementing CAPA, and contributing to the successful completion of many product validations and improved consistency in quality & yields. The highest importance was given to quality compliance, transparency, and second-line development. Resolved very critical queries related to Losartan and Olmesratan received from EDQM and USFDA Nitrosoamene and Azido impurities. Worked towards harmonization of practices across units. Strengthened cleaning validation practices and implemented required controls on recovered solvents. Implemented skip testing and reduced testing wherever it is possible. Did many advanced intermediate manufacturers audit in china and updated.

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  SATYADEEPTHA PHARMACEUTICALS LIMITED

  • Humnabad

  • Head Of Quality

    • Dec 2017 - Jun 2018
    • Humnabad

    Working as Head Quality, Responsible for QA & QC activities in entire site . Took a challenging task and contributed in developing quality systems , electronic controls in QC and upgraded entire site to face already announced USFDA audit in the month of JANUARY 2018 (second week) and also provided GMP training to entire team -current status : Faced USFDA audit successfully from 08.01.18 to 11.01.2018 , Auditor : Ms Cheryl A Clausen , submitted response within 15 working days .Now working on CAPA implementation ,training , GMP /GLP compliance , Validations , strengthening OOS & complaints etc . EIR received and second response was sent and finally closed .

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  Hetero Drugs Ltd

  • Hyderabad, Telangana, India

  • AVP QUALITY

    • Aug 2016 - Nov 2017
    • Hyderabad, Telangana, India

    Responsible for QA and QC activities unit 1

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  Piramal Enterprises Limited

  • Digwal

  • Head QA , QC

    • Jul 2015 - Jul 2016
    • Digwal

    Overall quality activities in digwal site .

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  Cadila Pharmaceuticals Limited

  • Ankleshwar

  • VP Quality

    • Aug 2011 - Jun 2015
    • Ankleshwar

    Head QA , QC for API units .

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  Unimark Remedies Ltd

  • Vapi

  • General Manager QA, QC

    • Aug 2010 - Aug 2011
    • Vapi

    Head QA , QC , Vapi unit.

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  Dr. Reddy's Laboratories

  • Hyderabad, Telangana, India

  • Associate Director

    • Aug 1988 - Aug 2010
    • Hyderabad, Telangana, India

    Worked in R&D , AR&D , TSD , QA / developed many quality systems from basic level .