Experience

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  Ratnatris Pharmaceuticals, subsidiary of Senores Pharmaceuticals

  • Ahmedabad, Gujarat, India

  • Asst.General Manager-Quality Assurance

    • Sep 2021 - Present
    • Ahmedabad, Gujarat, India

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  Shukra Pharmaceuticals Limited

  • Ahmedabad, Gujarat, India

  • Deputy General Manager - Shukra Pharmaceutical limited

    • May 2021 - Aug 2021
    • Ahmedabad, Gujarat, India

    Worked as Quality Head leading to QA and QC

• 

  Unison Pharmaceuticals Pvt. Ltd.

  • Ahmedabad, Gujarat, India

  • Quality Assurance Manager

    • Dec 2018 - May 2021
    • Ahmedabad, Gujarat, India

    Quality Assurance Manager with expertise in handling of gamut of functions assuring that quality system and procedure are appropriate, followed and controls are maintained during manufacturing.Expertise in implementation and maintenance of cleaning validation, process validation, hold time study, equipment qualification and computerized system validation Experience of handling of Quality Management System (Incident/Deviation, Manufacturing and market complaint Investigation, Trending Assessment, Root Cause Analysis, Change Control and CAPA), Health Authority Audit Response and Compliance.Work exposure of IPQA in Tablets, capsule, small volume parentrals, dry powder injection.

• 

  Mylan Laboratories Limited

  • Nashik

  • Deputy Manager- Quality Assurance

    • Jan 2010 - Dec 2018
    • Nashik

    1. Validation and Qualification (Cleaning / Process validation / Continoued Process verification)2. Quality Management System (Incidents, OOS/OOT, change control, CAPA, Market complaints and Internal Audit, Quality Risk assessment, Management Review Meeting, Health Authority Audit Response and Compliance)3. In process quality assurance (IPQA)4. Product Quality Review (PQR)5. Hold Time study 6. Engineering QA7. SOP Preparation.

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  Cadila Pharmaceuticals Limited

  • Ahmedabad Area, India

  • Technical Supervisor- Quality Assurance

    • Oct 2008 - Dec 2009
    • Ahmedabad Area, India

    IN PROCESS QUALITY ASSURANCE (IPQA)- Oral Solid Dosage Form, Dry Syrup and Dry Powder Injection1. Leading role in IPQA2. Line clearance2. In process checks and Monitoring3. Sampling of intermediates and Finished product4. Calibration of IPQA Instruments 5. Batch Document Review and compliance6. Batch Release (Packing to FG store)7. cGMP Compliance8. Master BMR documents review

• 

  Shreya Life Sciences Pvt. Ltd.

  • Aurangabad Area, India

  • Quality Assurance Officer

    • Jun 2007 - Oct 2008
    • Aurangabad Area, India

    IN PROCESS QUALITY ASSURANCE (IPQA)- Oral Solid Dosage Form, Small Volume parentrals1. Line clearance2. In process checks3. Sampling 4. Calibration5. Batch Document Review and compliance6. Batch Release (Packing to FG store)7. cGMP Compliance

• 

  Encore Healthcare Corporation

  • Paithan Area, India

  • Quality Assurance Trainee

    • Sep 2006 - Jun 2007
    • Paithan Area, India

    IN PROCESS QUALITY ASSURANCE (IPQA)- Oral Solid Dosage Form1. Line clearance2. In process checks3. Sampling 4. Calibration5. Batch Document Review and compliance6. cGMP Compliance