Empower 3
Ranjeet Sawant
Analytical Method Validation | Analytical Method Development | Quality Control | QMS
Gandhinagar
Summary
Experienced Analytical method and QMS Expert with extensive knowledge in Quality Management Systems, project management, Analytical method Development, Analytical method Validation. Proven track record in developing and managing analytical methods, document management systems, Regulatory activities, Quality assurance activities, reviewing the effectiveness of the product, assessing the statistical data pertaining to the product, ensuring safety, and creating reports of the findings.
Overview
9
9
years of professional experience
3
3
Languages
Work History
Executive Product Development
Torrent Pharmaceutical Ltd.
07.2025 - Current
- Responsible to execute Analytical Method Development, Method Validation, Verification, and Analytical Method Transfer for a diverse portfolio, including Drug Substances, Oral Solids and Injectables.
- Execute method equivalency protocols and pharmacopeia assessments while running forced degradation and stability studies to validate analytical reliability.
- Execute technical documentation for ANDA filings and resolve regulatory queries promptly to secure timely product approvals across global markets.
- Preparation of analytical method validation and analytical method transfer protocols and reports.
- Preparation of Specification and Standard Testing Procedure and Management of stability study data.
- GLP activities (SOP Preparation, Qualification of Instrument, Calibration of Instrument).
Senior Executive
Sandoz Pharmaceuticals Pvt. Limited
05.2023 - 06.2025
- Managed on-site document control team and developed efficient document management systems resulting in timely delivery of Lifetime Quality Records.
- Created master document templates and forms as needed to improve document management processes.
- Ensured site-based document management activities were in compliance with approved processes and procedures.
- Execution of Analytical method validation for Oral solid dosage, API & Injectable, etc.
- Prepared of analytical method validation protocols, reports, SOPs, assessment reports according to the guidelines.
Sr. Research Fellow
Emcure Pharmaceuticals Limited
09.2021 - 04.2023
- Response to FDA queries in timely manner
- Co-ordinated with various departments like clinical, Quality control teams
- Gained knowledge of Analytical method development analytical methods in pharmaceutical industry.
- Reviewed analysis results and compilation of the same.
- Prepared of analytical method validation protocols, reports, SOPs, assessment reports according to the guidelines.
- To perform familiarization, validation of methods as per the regulatory requirement, to follow ALCOA+ during work.
- Reviewed incoming and outgoing documents for compliance to requirements.
Executive
Alembic Pharmaceuticals Limited
05.2018 - 09.2021
- Manage the quality control functions and ensuring the compliance of GLP in line with regulatory needs & response to FDA queries in timely manner.
- Having demonstrable skill in preparation of reports, presentations, manuscripts & other documentations.
- Reviewing the effectiveness of the product, assessing the statistical data pertaining to the product, ensuring safety, and creating reports of the findings.
- Conduct analysis and validate the drug products – Tablets & Capsules determine the stability.
- Enhance expertise with Calibration of Dissolution Tester, Analytical Balance, pH meter, UV-Spectrophotometer and HPLC.
- Execution of Analytical method validation for Oral solid dosage, API & Injectable, etc.
- Ensured site-based document management activities were in compliance with approved processes and procedures.
Officer
Centaur Pharmaceuticals Pvt. Limited
09.2016 - 04.2018
- Enhance expertise with Calibration of Dissolution Tester, Analytical Balance, pH meter, UV-Spectrophotometer and HPLC.
- Identify the batches to store with regard to the stability testing in line with the standard operating procedure (SOP) and as per the regulatory market need.
- Perform test on the drugs through HPLC, GC, UV Spectrophotometer like Assay, Dissolution, Content Uniformity, Blend Uniformity, Related Substances.
- To perform familiarization, quality control activities as per the regulatory requirement, to follow ALCOA+ during work.
Education
Master of Science - Organic chemistry
SPPU
PuneSkills
GxP and Regulatory requirements
Analytical Method Validation
Analytical Method Development
Analytical Method Transfer
Microsoft Office, Document management, CAPA
Root Cause analysis
Incident handling
Effective Leadership
Instrumental skills HPLC, GC, GC-MS, IR, UV, Autotitrator etc
Software
Chromeleon 72
Lab Solution
Labware LIMS
Timeline
Executive Product Development
Torrent Pharmaceutical Ltd.
07.2025 - Current
Senior Executive
Sandoz Pharmaceuticals Pvt. Limited
05.2023 - 06.2025
Sr. Research Fellow
Emcure Pharmaceuticals Limited
09.2021 - 04.2023
Executive
Alembic Pharmaceuticals Limited
05.2018 - 09.2021
Officer
Centaur Pharmaceuticals Pvt. Limited
09.2016 - 04.2018
Master of Science - Organic chemistry
SPPU