SAP
Sachin Shinde
Quality Control Manager
Chh.Sambhajinagar
Summary
Experienced Quality Manager with a track record of driving improvements in quality and productivity. Demonstrates a deep understanding of tools and concepts in quality management and excels at implementing effective strategies for continuous improvement. Committed to ensuring strict adherence to quality legal standards, particularly Good Manufacturing Practices (GMP).
Overview
17
17
years of professional experience
4014
4014
years of post-secondary education
2
2
Certifications
2
2
Languages
Work History
QC Manager
Ipca Laboratories
02.2025 - Current
- Computer system validation lifecycle plan with risk base approach
- Making master validation plan
- Preparing the URS as per EU Annex 11
- Follow a framework for validating automated systems (GAMP 5)
- Preparation of master specification of the product in LIMS
- Risk Assessment – Identify risks and define mitigation strategies
- IQ, OQ and PQ of instrument
- Change control and audit compliance
Deputy Manager- QC
Ajanta Pharma limited
05.2018 - 01.2025
- Handling of shift management and daily work allocation
- Responsible for laboratory investigation (OOS, OOT and incident)
- Making URS of instrument and software
- Performed Instrument Qualification (IQ,OQ and PQ)
- Protocol preparation of Computer system validation and risk assessment as per GAMP 5
- Instrument categorization asper GAMP 5
- Responsible for laboratory investigation (OOS, OOT and incident)
- Responsible for audits and compliance in the laboratory
Asst. Manager- QC
Aarti drug limited
03.2017 - 05.2018
- Planning and monitoring of daily work of In-process, finished good section
- Handling the QMS activity (OOS, OOT, incident, deviation etc.) Audit trail review of instrument and complies as per 21 CFR parts 11
- Handling the troubleshooting of instrument
Sr. Executive -QC
Sun Pharmaceutical Ind.
03.2008 - 03.2017
- Analysis of routing product including peptide and cytotoxic
- Planning and monitoring of daily work of stability section
- Receiving of stability samples and maintaining their record
- Responsible for charging and withdrawal of stability samples
- Responsible for stability chamber management
- Responsible of stability trending of product
- Responsible for protocol preparation
- Handling of OOS and OOT of stability samples
- Fulfill the regulatory requirement such as USFDA, EDQM and ANVISA etc
- Performed risk assessment of stability chamber
Education
Master of Science - Biochemistry
New Arts, Commerce And Science Collage
Ahmednagar, Maharashtra10-2007
Bachelor of Science - Chemistry
New Arts, Commerce And Science Collage
Ahmednagar, Maharashtra04-2005
Skills
Proficient in EU Annex 11 Regulatory Standards
User Requirements Specification Preparation
Root Cause Identification
Skilled in ALCOVA Usage
Audit Experience
Stability Management
Timely Decision-Making Expertise
Savings Optimization Skills
Computer System Validation
Certification
FDA approved in chemical and instrumentation
Audit Faced
- USFDA (United State Food and Drug Administration)
- EDQM (European Directorate for the Quality of Medicines and Healthcare)
- PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
- ANVISA (Brazilian Health Regulatory Agency)
- WHO (World Health Organization)
- OHSAS 18001
Personal Information
- Date of Birth: 04/22/85
- Marital Status: Married
Hands On Experience
- FTIR spectrophotometer (Make: Shimadzu)
- UV/Vis spectrophotometer (1700-Pharmaspec Make: Shimadzu)
- Melting Point Apparatus (Make: Mettler Toledo)
- KF Titrator (Make: Mettler Toledo, Software: LabX)
- Auto-Titrator (Make: Mettler Toledo, Software: LabX)
- Polarimeter (Make: Autopol Rudolph)
- Coulometer (for peptide products water content) (Make: Mettler DL-39 Mettler)
- HPLC and UPLC (Make: Water’s; software: Empower-3)
- HPLC (Make: Shimadzu; software: Lab-solution)
- HPLC (Make: Agilent; software: Open-lab)
- GC (Make: Agilent; software: Open-lab)
- Particle Size analyzer Malvern 2000 and 3000 (Make: AMIL and PANalytical)
- X-ray Diffractometer (Make: PANalytical)
Software
LIMS
Timeline
QC Manager
Ipca Laboratories
02.2025 - Current
Deputy Manager- QC
Ajanta Pharma limited
05.2018 - 01.2025
Asst. Manager- QC
Aarti drug limited
03.2017 - 05.2018
Sr. Executive -QC
Sun Pharmaceutical Ind.
03.2008 - 03.2017
Master of Science - Biochemistry
New Arts, Commerce And Science Collage
Bachelor of Science - Chemistry
New Arts, Commerce And Science Collage