MS-Office
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
Change control & Deviation management
Review of Detailed Documents like Process Validation
Audit management
Preparation of Vendors Questionnaire
Handling of Customer Complaints
Training to Pharmacist
MS-Office
SAP
Oracle
Personal Information
Date of Birth: 11/09/79
Software
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