Sujeet Kumar Biswas
DGM QUALITY
- Role
- Quality Control Manager at Dr. Reddy's Laboratories
- Location
- Surat, IN
- LinkedIn followers
- 500 followers
About Sujeet Kumar Biswas
Diligent & result-oriented Professional with a gratifying career span of 18+ years predominantly in the Pharma Sector (Dr.Reddys Laboratory, Freesenius-Kabi, Ipca Laboratory, Syncom heath Care LTD, NGB Laboratories Pvt.Ltd, Dewas Soya LTD) in the areas of Product Development & Management as per cGMP, Quality Audits, Quality Systems Implementation, OOS investigation, OOT Investigation, Incident Investigation, Safety Observation & Investigation(SOI) audit, Quality Observation & Investigation(SOI) audit, Change control handling.• LIMS DEVELOPMENT AND IMPLEMANTATION IN THE LAB.• LIMS core team handling as team leader (LIMS, software Labware 7.0 version, pharma LIMS 3.2 version), handled team size 24.• Empower3 and SAP expertise, interface. • Responsible to provide training to whole lab about LIMS and Empower. Instant Problem solving for end user (Analyst, supervisor, AQA team).• Working coordination with IT-BPE team to implementation of automation & simplification in the Lab.• Reporting & Documentation, Regulatory Compliance and General Management, LDM (Lean Daily Management) implementation. 5’s implementation, SOI (Safety Observation & Interaction), Continuous improvement project (part of Operation Excellence).• Significant experience of modern concepts of ensuring quality of product by using tools of ICH as Validation, Equipment & Instrument Qualification; reviewed activities of qualification including tablet, capsule, suspensions, dry powder & liquid injectables dosage forms in formulation unit.• Demonstrated competencies in deriving substantial improvements across diverse business processes with implementation of latest Quality Management Tools; deft in preparing the Quality Assurance Plans (QAP) SOPs, and analyzing Customer Complaints through CAPA Plans.• Successfully involved in various audits - USFDA, MHRA, TGA, ANVISA,MCC, RUSSIA, EU GMP, GHANA, UGANDA, WHO, IDMA, Local FDA & Various customer audits; currently spearheading efforts with Dr. Reddy’s Laboratory Limited, Hyderabad as Assistant Manager – Quality Control
Experience
Quality Control Manager
Mar 2010 — Present
Education
Devi Ahilya Vishwavidyalaya, Indore
Bachelor's degree
1998 — 2001
MP Board
Class X
MP Board
Class XII
Holkar Science College, DAVV University
Bachelor of Science (B.Sc.)
All India society for Electronic and Computer technology
Post Graduate Diploma
Devi Ahilya Vishwavidyalaya
Bachelor's degree
1999 — 2001
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