Amit Galande

Amit Galande Email and Phone Number

Quality Management System Professional at Serum Institute of India Pvt. Ltd. @ Serum Institute of India Pvt. Ltd.
pune, maharashtra, india
Amit Galande's Location
Pune, Maharashtra, India, India
Amit Galande's Contact Details

Amit Galande work email

Amit Galande personal email

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About Amit Galande

Amit Galande is a Quality Management System Professional at Serum Institute of India Pvt. Ltd. at Serum Institute of India Pvt. Ltd..

Amit Galande's Current Company Details
Serum Institute of India Pvt. Ltd.

Serum Institute Of India Pvt. Ltd.

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Quality Management System Professional at Serum Institute of India Pvt. Ltd.
pune, maharashtra, india
Website:
seruminstitute.com
Employees:
2246
Amit Galande Work Experience Details
  • Serum Institute Of India Pvt. Ltd.
    Quality Management System Professional
    Serum Institute Of India Pvt. Ltd. Mar 2021 - Present
    Pune, Mh, India
    Work in Production compliance department as a QMS coordinator for, Change Control Management, Deviation and CAPA Management, Compliance to audit observations. Worked in the pandemic pressure for Covishield Vaccine manufacturing in accordance with compliance to the every batches. Worked smartly to complete Deviation, investigation, CAPA and change control on time to release batches early in the market.
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  • Enzene Biosciences Ltd
    Project Development Specialist - Injectables
    Enzene Biosciences Ltd Apr 2019 - Feb 2021
    Pimpri Chinchwad, Mh, India
    Worked on green field project from URS phase to product clinical trial batches. Taken initiative, troubleshooting in different activities like URS, DQ, FAT, SAT, IQ, OQ, PQ, Media filling, CT batches, etc to meet project timeline as per scheduled time line. Hands on experience formulation and filling with different products manufactured in Cartridge, Vial and PFS. Managed teams to achieve goals of formulation and aseptic filling operations. Reporting deviation, investigation preparation and closure with appropriate CAPA.
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  • Stelis Biopharma
    Qualification And Validation Expert - Injectables
    Stelis Biopharma Mar 2017 - Apr 2019
    Bengaluru, Karnataka, India
    Worked from start of qualification of the Fill Finish line till successful media fill runs. Preparation and review of qualification documents like URS, DQ, CLIA, QRM, IQ, OQ and PQ. Involved in the qualification activities of Filter Integrity machine, Autoclave, DHS, Terminal steriliser, Lyophilizer and Filling Machine.
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  • Biocon
    Insulin Production Expert
    Biocon Sep 2014 - Mar 2017
    Bengaluru, Karnataka, India
    View

Amit Galande Education Details

Frequently Asked Questions about Amit Galande

What company does Amit Galande work for?

Amit Galande works for Serum Institute Of India Pvt. Ltd.

What is Amit Galande's role at the current company?

Amit Galande's current role is Quality Management System Professional at Serum Institute of India Pvt. Ltd..

What is Amit Galande's email address?

Amit Galande's email address is am****@****ute.com

What schools did Amit Galande attend?

Amit Galande attended Bangalore University.

Who are Amit Galande's colleagues?

Amit Galande's colleagues are Santosh Ghadge, Anuj Atreya, Akash Bhadange, Vinayak Gupta, Vishal Dorugade, Shubham Gaikwad, Avinash Pawar.

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