Summary
Overview
Work History
Education
Skills
Personal Information
Software
Timeline
Generic
AMAR I. SAWALKAR

AMAR I. SAWALKAR

Corporate Quality Assurance
Navi Mumbai,MH

Summary

B. Pharma M.B.A with Experience in the area of pharmaceutical field & Implementing audit. As per EOU.

Overview

20
20
years of professional experience
3
3
Languages

Work History

Manager Corporate Q A (Loan Licensing)

Murli Krishna Pharma Pvt. Ltd
04.2022 - Current
  • FDA Applications
  • CDSCO Application
  • Licensing process
  • Tendering Documentation
  • Internal Inspection
  • Audit report preparations
  • Third Party Mfg
  • Site Approval
  • Preparation and presentation of MIS Reports

Titan Lab Pvt. Ltd.
11.2019 - 04.2021
  • Responsible for Deviation & Change management
  • Team leader as Internal Audit team
  • (Auditor and Auditee)
  • Document Issuance
  • Audit Compliance & Report Preparation
  • Market Complaint Investigation
  • Training to new Joining Chemist
  • Preparation VQ
  • Handling of Customer Audit
  • SOP preparations
  • Preparation of yearly Trends

Sava Health Care
04.2018 - 11.2020
  • Responsible for Deviation & Change Control management
  • Team leader as Internal Audit team
  • (Auditor and Auditee)
  • Document Issuance
  • Audit Compliance & Report Preparation
  • Market Complaint Investigation
  • Training to new Joining Chemist
  • Preparation VQ
  • Handling of Customer Audit
  • SOP preparations
  • Preparation of yearly Trends

Sr. Executive

Chemspec Chemicals Pvt. Ltd.
02.2016 - 04.2018
  • Responsible for Deviation & Change Control management
  • Document Issuance
  • Audit Compliance & Report Preparation
  • Market Complaint Investigation
  • Training to new Joining Chemist
  • Preparation VQ
  • IPQA I/C
  • Handling of Customer Audit
  • APQR Preparation
  • Process Validation Protocol and Report Preparation

Shalina Lab Pvt. Ltd.
03.2011 - 02.2016
  • SOP Preparation
  • IPQA in charge
  • Change Control & Deviation management
  • Equipment Qualification
  • Process Validation
  • Market complaint Handling
  • Document Issue
  • SMF Preparation
  • Batch Release ERP

Agio Pharmaceuticals Ltd.
03.2010 - 02.2011
  • Handling of Production Plan
  • PPIC Work
  • Material & Change part management
  • Preparation of MIS Report

Wockhardt Ltd.
03.2008 - 02.2010
  • Handling of Shift work
  • Implementation of GMP
  • Execution of Production plant
  • Responsible for Shop Floor activity
  • Preparation of WIP Report
  • Entry of Batches in SAP
  • Manpower allocation
  • Co-ordination with QA/QC

Emcure Pharmaceutical
02.2005 - 02.2008
  • Handling of Shift work
  • Implementation of GMP
  • Execution of Production plant
  • Responsible for Shop Floor activity
  • Preparation of WIP Report

Education

M.B.A. - International Business Management

SPPU

B. Pharmacy - undefined

Pune University

D. Pharmacy - undefined

MSBTE

Skills

Preparation of SOP & SCP

Personal Information

Date of Birth: 11/09/79

Software

MS-Office

SAP and ERP

Timeline

Manager Corporate Q A (Loan Licensing)

Murli Krishna Pharma Pvt. Ltd
04.2022 - Current

Titan Lab Pvt. Ltd.
11.2019 - 04.2021

Sava Health Care
04.2018 - 11.2020

Sr. Executive

Chemspec Chemicals Pvt. Ltd.
02.2016 - 04.2018

Shalina Lab Pvt. Ltd.
03.2011 - 02.2016

Agio Pharmaceuticals Ltd.
03.2010 - 02.2011

Wockhardt Ltd.
03.2008 - 02.2010

Emcure Pharmaceutical
02.2005 - 02.2008

B. Pharmacy - undefined

Pune University

D. Pharmacy - undefined

MSBTE

M.B.A. - International Business Management

SPPU

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AMAR I. SAWALKARCorporate Quality Assurance