Akshay Shinde
Mapusa
Summary
Expertise in HPLC and LC–MS method validation, stability–indicating methods, and impurity profiling in compliance with ICH Q2(R1) guidelines. Proven track record of participating in USFDA inspections, ensuring full compliance with 21 CFR Parts 11, and maintaining data integrity (ALCOA )
Overview
7
7
years of professional experience
1
1
Certificate
Work History
Senior Officer
Centaur Pharmaceutical Pvt. Ltd.
Pune
06.2025 - Current
- Provide analytical support for USFDA-regulated drug product development under GMP conditions.
- Perform and review chromatographic data ensuring data integrity, audit trail review, and system suitability compliance.
- Support batch release testing and stability studies using validated analytical methods.
- Ensure laboratory documentation meets USFDA inspection and regulatory expectations.
Research Associate
Macleods Pharmaceutical Ltd.
Pune
08.2023 - 07.2025
- Executed ICH Q2(R1) compliant analytical method validation using HPLC and LC-MS/MS for APIs and finished dosage forms.
- Conducted validation parameters including accuracy, precision, specificity, linearity, robustness, and range.
- Performed forced degradation and stability-indicating studies to support regulatory filings.
- Led analytical method transfer activities from R&D to QC, ensuring reproducibility at commercial scale.
- Authored validation protocols, reports, and analytical summaries supporting regulated market submissions.
- Supported internal audits and USFDA readiness activities.
Executive, Analytical Development (R&D)
Deepak Novochem Tech. Ltd.
Pune
10.2022 - 08.2023
- Conducted impurity profiling and assay determination for APIs and raw materials.
- Supported analytical method development and optimization aligned with GMP expectations.
- Prepared validation protocols, technical reports, and regulatory support documentation.
- Ensured compliance with data integrity and controlled documentation practices.
Quality Control Officer
USV Private Limited
Mumbai / Pune
05.2019 - 10.2022
- Actively participated in USFDA inspections, supporting investigators with raw data, SOPs, and analytical justification.
- Maintained full compliance with GLP, GMP, GDP, and ALCOA+ data integrity principles.
- Managed QC sample lifecycle using Caliber LIMS, ensuring traceability and audit trail compliance.
- Performed routine, in-process, and stability testing supporting US and regulated market supplies.
- Conducted instrument calibration, qualification, and troubleshooting as per SOPs.
Education
MSc - Organic Chemistry
01-2018
BSc - Chemistry
01-2016
Skills
- Communication
- Teamwork
- Critical thinking
- Time management
- Leadership
- Adaptability
Certification
- MS CIT (Information Technology)
- SAP Fundamentals
- LIMS Professional Training
Timeline
Senior Officer - Centaur Pharmaceutical Pvt. Ltd.
06.2025 - Current
Research Associate - Macleods Pharmaceutical Ltd.
08.2023 - 07.2025
Executive, Analytical Development (R&D) - Deepak Novochem Tech. Ltd.
10.2022 - 08.2023
Quality Control Officer - USV Private Limited
05.2019 - 10.2022
University - MSc, Organic Chemistry
University - BSc, Chemistry
Languages
- English
- Hindi
- Marathi
Personal Information
- Title: Analytical Scientist
- Date of Birth: 05/07/96
Regulatory Audit Experience
- USFDA Inspections
- MHRA, WHO, PMDA Audits
- 21 CFR Part 210, 211, 11 Compliance
Software Systems
- CALIBER LIMBS & TIAMO
- SAP – DATA Manipulation
Work Authorization
Open to regulated market roles.
Languages
- English
- Hindi
- Marathi
Personal Information
- Title: Analytical Scientist
- Date of Birth: 05/07/96
Regulatory Audit Experience
- USFDA Inspections
- MHRA, WHO, PMDA Audits
- 21 CFR Part 210, 211, 11 Compliance
Software Systems
- CALIBER LIMBS & TIAMO
- SAP – DATA Manipulation