Experience

Mac-Chem Products India Pvt. Ltd.

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Documentation officer Production Sterile API

  • Feb 2022 - Present

  - Handling Quality Management System related activity (Change control, Deviation). - Preparation of investigation report of OOS,OOT, Market compliant - Preparation of Quality evaluation. - Preparation of SOP. - Preparation & review of MPCR & BPCR. - Review of Qualification protocol & report. - Review of validation protocol & report. - Review of Process validation protocol & report. - Review specification as per current pharmacopeia monograph. - Coordination with user department for QMS related activity. - Maintaining complete status of regulatory documents. - Post Approval changes regarding regulatory documents. - Good understanding of cGMP. - Basic knowledge of ICH Guidelines. Show less



UNIVED HEALTHCARE PRODUCTS PRIVATE LIMITED

• India
• Mining

• Quality Control

  • Aug 2019 - Dec 2021

  - Preparation of COA (RM,PM & FG) - Preparation of Specification (RM,PM & FG) - Review of calibration record of analytical instruments. - Review of working standards and reference management program. - Sampling and testing of PM and RM. - Good understanding of cGMP. - Preparation of COA (RM,PM & FG) - Preparation of Specification (RM,PM & FG) - Review of calibration record of analytical instruments. - Review of working standards and reference management program. - Sampling and testing of PM and RM. - Good understanding of cGMP.



BEE Pharmo Labs Pvt Ltd

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Internship Trainee

  • Jun 2017 - Jun 2017

  - Chemical tests. - Intrumental tests - Microbiological tests - Biological tests. - Chemical tests. - Intrumental tests - Microbiological tests - Biological tests.