Sachin Shinde
Ahmednagar
Summary
Intelligent Quality Manager with talents in monitoring production quality and improving productivity. Deep understanding of the tools and concepts that go into quality management. Flexible, reliable and ensure standards meet expectations and legal compliance.
Overview
16
16
years of professional experience
Work History
Deputy Manager- QC
Ajanta Pharma limited, Waluj, Aurangabad.(FDA approved)
Chh.Sambhaji Nagar
05.2018 - Current
- Handling of shift management and daily work allocation.
- Timely release the batches of finished goods, intermediate, in-process samples and raw material
- Maintained inventory accuracy by counting stock-on-hand and reconciling discrepancies.
- Mentored staff to enhance skills and achieve daily targets, using hands-on and motivational leadership.
- Implemented training processes for newly hired employees.
- Planning and executing the batch management program for dispatch within timeframe.
- Responsible for laboratory investigation (OOS, OOT and incident).
- Responsible for audits and compliance in the laboratory.
- Performed software qualifications of instrument
- Performed root cause analysis and risk assessment (FEMA).
- Monitored daily operations and ensured compliance with company policies and regulations.
- Coordinated with other departments to ensure smooth functioning of activities.
- Provided guidance and support to team members to help them achieve goals.
Asst. Manager- QC
Aarti drug limited, Unit-E-22, Tarapur
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.
Ahmednagar
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,Maharashtra01-2008
Bachelor of Science - Chemistry
New Arts, Commerce And Science Collage
Ahmednagar, Maharashtra03-2005
Skills
- Quick Decision-Making Abilities
- Cost Analysis and Savings
- Performance Improvements
- Purchasing and Planning
- Expertise in Software such as SAP HANA, LIMS etc
- Employee Performance Evaluations
Accomplishments
Attended the X’ radiate (XRD) Seminars on Polymorphism
Hands On
TarapurAartiWaluj
- FTIR spectrophotometer (IR-Prestige-21 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)
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)
- ANVISA (Brazilian Health Regulatory Agency)
- WHO (World Health Organization)
- OHSAS 18001
Personal Information
- Date of Birth: 04/22/85
- Marital Status: Married
Affiliations
- Pursuing the course ' PGDM Executive in Global Logistics and Supply Chain Management’ from MIT School of distance Education Pune. ( Dec-2023 to till)
Languages
Marathi
First Language
English
Intermediate (B1)
B1
Timeline
Deputy Manager- QC
Ajanta Pharma limited, Waluj, Aurangabad.(FDA approved)
05.2018 - Current
Asst. Manager- QC
Aarti drug limited, Unit-E-22, Tarapur
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
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