Amitava Saha
Master In Pharmacy
Ahmedabad
Summary
- Led pharma production in a dynamic global MNC
- Managed quality improvement projects for business alignment
- Expertise in QHSE (Quality, Health, Safety, and Environment) policies, GMP, sanitation, and housekeeping
Overview
15
15
years of professional experience
1
1
Certification
Work History
Quality Management System
Torrent Pharmaceuticals Ltd.
08.2015 - Current
- Continuous reviews of the quality management system
- Investigated and improved deviations in Tablet and Capsule Department for compliance
- Implemented timely Corrective Action and Preventive Action (CAPA) based on deviation reports
- Managed change controls, deviations, and incidents with cross-functional teams
- Conducted regular internal audits and gap analyses for compliance and regulatory requirements
- Provided comprehensive Evaluation Reports for production activities
- Assisted in production risk assessment and developed risk assessment models for compliance risks
- Proficient in Trackwise System for managing deviations, OOS, OOT, Market Complaints, and CCF
- Hands-on experience in preparing QMS for Tablet and Capsule Department
- Expertise in generating comprehensive Quality Metrics for departmental performance
- Participated in internal audits of the quality management system
Production
Torrent Pharmaceuticals Ltd.
05.2010 - 08.2015
- Established Granulation – IV unit with multiple granulation, blender, compression, and coating areas
- Managed validation processes, ensuring timely day-to-day production
- Provided technical support and documented manufacturing processes
- Optimized production scheduling, minimizing costs for improved efficiency
- Orchestrated activities and managed details from pre-production to post-production
- Implemented tracking and quality control systems to address production problems
- Led daily and weekly production meetings, created schedules, and oversaw logistics
- Monitored production progress, maintained reports, and addressed issues promptly
- Collaborated with production workers for a smooth production line operation
- Trained and supervised personnel, resolved issues, and maintained accurate production records
Validation
Ranbaxy Lab Ltd
08.2009 - 05.2010
- Assisted in facility commissioning, qualification, and validation processes
- Developed, reviewed, and recommended changes to validation procedures
- Contributed to method development and validation in different matrices
- Documented the entire validation process, noting any changes or alterations
- Conducted method qualification and validation for drug substance release
- Collaborated with cross-functional teams to identify and resolve validation issues
- Scheduled validations with section supervisors, ensuring timely completion
- Initiated, performed, documented, and approved data validations.
Validation
Ranbaxy Lab Ltd
02.2009 - 08.2009
- Assisted in facility commissioning, qualification and validation.
- Supported validation and qualification testing of pharma equipment.
- Developed, reviewed and recommended changes to validation procedures.
- Assisted with equipment and method qualification and validation activities.
- Performed method qualification and validation for drug substance release.
Education
Diploma in Project Management - Management
I.P.E.R (Pune)
Pune 04.2001 -
Masters in Pharmacy - Pharmaceutical Sciences
KMIPS Rourkella
Orissa 04.2001 -
Bachelors of Pharmacy - Pharmacy
CPS Mohuda
Behrampur Orissa 04.2001 -
Science Education
MGM HS School
Agartala2002
Skills
Document Control
Internal Auditing
Corrective Actions
Quality Management
Standard Operating Procedures
Communication
Relationship Building
Certification
Lachman Training - Handling of QMS system (Investigation, selection of tools, CAPA etc)
Timeline
Lachman Training - Handling of QMS system (Investigation, selection of tools, CAPA etc)
11-2022
Quality Management System
Torrent Pharmaceuticals Ltd.
08.2015 - Current
Production
Torrent Pharmaceuticals Ltd.
05.2010 - 08.2015
Validation
Ranbaxy Lab Ltd
08.2009 - 05.2010
Validation
Ranbaxy Lab Ltd
02.2009 - 08.2009
Diploma in Project Management - Management
I.P.E.R (Pune)
04.2001 -
Masters in Pharmacy - Pharmaceutical Sciences
KMIPS Rourkella
04.2001 -
Bachelors of Pharmacy - Pharmacy
CPS Mohuda
04.2001 -
Science Education
MGM HS School