Deepak Kachare
Pune,MH
Summary
Versatile Assistant General Manager with 24 years of experience in Pharmaceutical Industry. Offers progressive experience combined with sound judgement and good problem-solving abilities. Adaptable in changing environments with strategic decision-making skills.
Looking out for a challenging career within IT domain of Pharmaceutical & Biotech Industry that provides an opportunity for IT system implementations aimed at Digitalization & Automation.
Overview
27
27
years of professional experience
1
1
Certification
Work History
Assistant General Manager IT
Enzene Biosciences Ltd.
01.2022 - Current
- Leading computer system implementations, computer system validations, compliance and support for GxP IT systems.
- Responsible for computer system validation of all GxP software and software-based systems as per best practices and in compliance to regulatory requirements.
- Responsible for ensuring compliance of all GxP software and software-based systems to applicable regulations.
- Responsible for Implementation of processes and best practices for electronic data security and integrity.
- Ensure on-going support to cross functional teams for smooth operation of computerized systems.
Manager Quality IT (CQA)
Cipla Ltd.
09.2000 - 12.2021
- Implementation of new systems in Quality domain including at overseas units.
- Providing support for Computer system validations to cross functional teams.
- Technical guidance and decisions.
- Project and resource planning.
- Identification of new technologies and systems for Strengthening quality systems.
- Process optimizations as part of new implementations.
- Coordination with Vendors and support partners.
- Manufacturing equipment IT systems compliance review and coordination for remediation.
Chemist
Advanced Technology Devices
10.1997 - 09.2000
Role - Contamination control testing of parts and finished products i.e Head Stack assembly for Hard Disk Drives and Contamination control activities for clean rooms.
Responsibilities
- Chemical analysis of head stack assembly and parts for contamination control.
- Usage and management of sophisticated analytical instruments like Ion Chromatograph, Micro Balances, FTIR, Computerized UV-Vis Spectrophotometer, Liquid Particle Counter, GCMS with Head Space Analyzer and Scanning Electron Microscope.
- Cleanroom audits, conducting contamination control awareness trainings.
- Development and optimization of cleaning cycles for mechanized cleaning of components.
Education
M.Sc. - Physical Chemistry
Mumbai University
Mumbai, MH05.1997
B.Sc. - Chemistry
Mumbai University
Mumbai, MH05.1995
Skills
- Team player, excellent coordination skills
- Perseverance
- Good communication skills
- Project management & Operations management
- Quick learning ability
- Strong problem management and mitigation
- Process Improvement
Accomplishments
Awarded the
Languages
English
Hindi
Marathi
Trainings & conferences
- CSV & 21 CFR Part 11 Compliance by Michel Gragnani, K2C
- Software Validation for the New FDA Inspections by David Nettleton, Global compliance panel
- Computer System Validation by Timur Kabadayi, Conval group
- Prince 2 project Management
- Project Management Principles by KT Upadhyaya, Triumphsys
- LIMS Admin 1 Certification (Attendance ID LW-0008178) & others like LIMS Basic, Crystal Reports, etc. for LabWare LIMS
- GAMP5 & 21 CFR Part 11 Compliance with Computer System Validation by Kalpesh R Vaghela, Infra Control Systems.
- Computer systems validation & Software assurance week by Informa connect
- Manufacturing and Quality Symposium organized by MasterControl
Personal Information
- Father's Name: BABANRAO S. KACHARE
- Date of Birth: 04/19/74
- Marital Status: Married
Certification
LIMS Admin 1 Certification (Attendance ID LW-0008178) & others like LIMS Basic, Crystal Reports, etc. for LabWare LIMS.
Additional Information
Systems implemented and supported
▪ Laboratory Information Management system - LabWare LIMS , Caliber LIMS
▪ Quality Management System - TrackWise
▪ Cleaning Validation System - CLEEN
▪ Enterprise Resource Planning - SAP
▪ Manufacturing Execution System / Batch Recording - Werum PAS-X
▪ Chromatographic Data System - Chromeleon
▪ Learning Management System - SAP Successfactors
▪ Document Management System – Documentum, MasterControl, Caliber DMS
▪ User Management System - E-Admin
▪ R& D systems like Clinical Trial Management System - Oracle
▪ Regulatory Affairs eCTD - Extedo
▪ Track & Trace systems - Tracelink & Centrack
▪ Annual Product Quality Report Generation System - Caliber QAMS
Timeline
Assistant General Manager IT
Enzene Biosciences Ltd.
01.2022 - Current
Manager Quality IT (CQA)
Cipla Ltd.
09.2000 - 12.2021
Chemist
Advanced Technology Devices
10.1997 - 09.2000
M.Sc. - Physical Chemistry
Mumbai University
B.Sc. - Chemistry
Mumbai University
Similar Profiles
PRANJAL JAINPRANJAL JAIN
Executive - Regulatory Affairs at Enzene Biosciences LtdExecutive - Regulatory Affairs at Enzene Biosciences Ltd
Navaneeth BNavaneeth B
Assistant Manager at Enzene Biosciences Ltd.Assistant Manager at Enzene Biosciences Ltd.
PRAVEENA PENTAKOTAPRAVEENA PENTAKOTA
Project Coordinator at Enzene Biosciences LtdProject Coordinator at Enzene Biosciences Ltd