amar sontakke
Executive Officer
About
Building up a challenging career opportunity in a competitive field & environment, which encourages flexibility in work, innovation, helps in honing the leadership skills along with teamwork, contributing to the growth of the company and self.
Skills & Expertise (11)
Work Experience
Production / R&D Executive Officer
Serum Institute of India Pvt. Ltd.
Jun 2016 - Present
Working in Rotavirus Vaccine Department, looking after Cell Culture, Virus Culture, Media Preparation, Equipment/Instrument qualifications, Area qualifications, Process Validation, Environmental Monitoring, Continued Compliance. Experienced in Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) & current Good Manufacturing Practices (cGMP) compliances. Experience in equipment/instrument qualifications and document preparation such as GxP, URS, DQ, IQ, OQ, PQ, IOQ, EEQ, Change Control Management, Deviation system, and other Quality Assurance (QA) & Quality Control (QC) related documents. Well equipped with HVAC-ACR/CR Continued Compliance Management. Preparation of Standard Operating Procedures (SOPs), training the new employees, preparing TNI. Handling of SAP system in production related modules. Acquainted with eVLMS, eLMS, eDMS softwares along with QMS systems such as change control and deviation. R&D on establishing Inactivated Rotavirus Vaccine (IRV), a thermally inactivated virus vaccine. Worked on iCellis-500 Bioreactor (pilot batches), RC-40 (PV batches with scaling up to Production level in near future). New vendor development, facility visits of vendors including FATs.
Education
SSC - CBSE
- 2009 · Afghanistan
HSC - CBSE
- 2011 · Afghanistan
B.Sc. (Industrial Microbiology/Microbiology) - Savitribai Phule Pune University
- 2014 · Afghanistan
M.Sc. (Microbiology) - Savitribai Phule Pune University
- 2016 · Afghanistan
MBA (Human Resource Management) - Jaipur National University
- 2021 · Afghanistan
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Skills (11)
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