Kalyan Shabade
Latur
Summary
Detail-oriented Pharmacy Graduate with 13 years of experience in Quality Operations and Management Systems. Currently contributes to process optimization at Dr. Reddy's Laboratories through effective communication and problem-solving tools. Skilled in LIMS, DCMS, Empower, and data analysis, with a strong focus on root cause analysis, incident investigation, and CAPA implementation.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Team Member V4
Dr. Reddy's Laboratories
Hyderabad
05.2016 - Current
- Implemented full kitting and 5S system, resulting in increased productivity.
- Cost saving up to 30 lakh p.a.by applying Strategic procurement of Chemicals and materials.
- Implemented Lean Daily Management (LDM), enhancing quality delivery and productivity.
- Fostered Kaizen culture through cross-fertilization of ideas and knowledge-sharing sessions.
- Supervised day to day operations to meet performance quality and service expectations.
- Handling of OOS, OOT & different type Deviations and CAPA management.
- Review of Analytical documents and Audit trials for Empower and standalone instruments.
- Review of Audit trials, SOPs, protocols, Compilation reports and all site documents
- Participated in audits conducted by European Union (EU), GHC, WHO Geneva, Russian Audit, and Ukraine Audit.
Management Staff QC
Cipla Ltd
Goa
03.2015 - 05.2016
- Supported USFDA audit at Cipla Goa in April 2015 by verifying adherence to regulatory standards, enhancing audit readiness.
- Prepared synopses and viva annexures for OOS, OOT, and deviations to facilitate regulatory review and compliance.
- HPLC & wet analysis of Tablets, Capsules, Creams, Ointments and Gels.
- Conducted stability studies for OSD and semi-solid products to ensure product integrity and compliance.
Quality Control Sr. Officer
Sterling Healthcare Limited
Pune
09.2012 - 03.2015
- Conducted HPLC and wet analysis to ensure quality of tablets and capsules.
- Executed stability studies to determine shelf life of finished products, supporting regulatory compliance.
- Developed stability protocols to ensure compliance with regulatory standards.
- Performed dissolution profile testing and comparative studies to assess formulation effectiveness.
- Assisted in European Union (EU) audit to verify compliance with quality standards.
- Sampling Of Raw materials, Active & Excipients.
Education
Bachelor of Pharmacy - First Class
Shivaji University
Kolhapur06-2012
Diploma in Pharmacy - Distinction
Dagdojirao Deshmukh College Of Pharmacy
Latur01-2009
Skills
- Quality Management System
- Quality Assurance
- Deviation & CAPA Management
- Risk Assessment
- 5S Methodology
- Lean management system
- SOP preparation
Certification
- LSSSDC (Life Science sector skill development council) Certified Analyst
- FDA Approved Quality control Analyst
- Six sigma White Belt Certified
Accomplishments
- Worked As 'Water Ambassador' for FTO-2 Unit
- Worked As Quality Star Cap
- Lean Six Sigma White belt
- Auto processing at Empower
- Stability Auto trending
Personal Information
- Date of Birth: 06/10/90
- Gender: Male
- Marital Status: Married
Languages
- Hindi
- Marathi
- English
Address - Permanent
Khadak Hanuman Papvinash Road, Latur, Maharashtra, 413512
Timeline
Team Member V4
Dr. Reddy's Laboratories
05.2016 - Current
Management Staff QC
Cipla Ltd
03.2015 - 05.2016
Quality Control Sr. Officer
Sterling Healthcare Limited
09.2012 - 03.2015
Bachelor of Pharmacy - First Class
Shivaji University
Diploma in Pharmacy - Distinction
Dagdojirao Deshmukh College Of Pharmacy