Ranjit Ranjan Rath

Assistant Manager Production,PPIC,Audit Compliance

M/s Cipla Ltd

Himachal pradesh

08.2005 - 10.2016

Contaract manufacturing (Granulation,compression,coating,pellet coating) & Supply chain,Technology transfer and QMS activities.Supports for Audit and Coordination with Business development (In Cipla Ltd more than 11 Yrs.)
Proven Track record of facing various regulatory audits like,USFDA,ANVISA,Health
Canada,MCC,TGA,TFDA,WHO,INVIMA Etc successfully different times of my carrier
FDA Approved chemist in Tablet manufacturing
Audit and compliance
Implementation of CAPA in shop floor
Cost reduction implementation in shop floor (manufacturing and packing) by lean manufacturing
Team building and their talent utilization on various activities in manufacturing and Contract manufacturing and packing
Green field projects and their successful implementation
CURRENT RESPONSIBILITIES
Overall responsible for production and production compliance
Execution of batches from Pilot scale to commercial batch size
Review of calculation of minimum and maximum batch sizes for regulatory filing based on equipment suitability
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Responsible for review of scope, scheme, batch size & equipment comparison for optimization/ validation and manufacturing of optimization / validation batches of different products
Responsible for review of optimization, validation and commercial batch manufacturing and packing records, process validation protocol & reports
Involvement in technical troubleshooting, handling quality defects and successful transfer of technology to commercial production
Responsible for review of Investigation reports for Out of Specification (OOS)
Responsible for review of Technology Transfer Protocol for site transfer products
Responsible for internal audits viz: Production, QA, Engineering, HR, and compliance and laid standards of the current good manufacturing practices
Responsible for review of deviation, incident and change control which are related to products process/equipments/area
Investigation of process deviation, non-compliance, market complaint, product failure and out of specification
Review of Qualification Protocol and Report and other auditable documents
Responsible for review of new SOP and existing SOP revision
Modification of existing SOP in coordination with QA and engineering.
Day to day productivity discussion, active participation in the cross functional team for exhibit batches, guidance to juniors for simplification of process flow without affecting to quality of the product
Compliance checking of preventive maintenance schedule and calibration of equipment
To carry out and review routine documentation as per regulatory requirement
Actively involved in infrastructure development and hiring of personnel for operation
Responsible for weekly and monthly production planning & its execution, training schedule, internal audits and preparation of User Requirement Specification for the new equipment
Vendor finalization on technical basis, FAT and design of area for new projects, line flow and equipment placement
Key member for the internal audit team
Act as SME (Subject matter expert) during the audits like USFDA,TGA,WHO and other regulatory audits
ACCOMPLISHMENTS
Troubleshooting of technical problems occurring during granulation, compression and coating
Support to quality assurance and regulatory affairs department for regulatory documents submission
Good knowledge and skills in granulation, compression, tablet coating, and wruster (pellet) coating viz., film coating, and enteric coating
Preparation of SOPs and qualification documents
Faced US FDA auditor regarding the system and executed products
Actively and successfully faced MCC, WHO (Geneva), EU audits
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Familiar in maintaining harmonious relationship with workmen and other departments
Conducting training programs in the departments and evaluation of the same
A team member of Productivity improvement team
Having strength of knowledge in all Departments to coordinate with Effective Production Planning and execution with orientation towards productivity
JOB RESPONSIBILITIES AND KEY SKILLS
Production planning and scheduling with material and manpower requirement
Reporting and reviewing of daily production and progresses with respect to product, equipment’s
Planning & organizing skills
Handling of various Projects
To produce product with quality parameter and observation of area condition
Timely completion of statuary documents and production documentation
Handling of manufacturing investigation, change control, Internal Audits,CAPA,Quality risk assessment,OOS,OOT like failures
Implement proper work practice in order to avoid contamination and mix up
To study processes and capacities so as to improve productivity
To learn or improve performing skills for better output & multi Task developing
Documentation, reviewing of SOP in compliances with cGMP
Compliance checking of preventive maintenance schedule
Timely taking measure to protect from damage, mishandling and accidents
Safety precaution taken in production
On time release of Production plan scheduling for next month
Timely availability of RM/PM Inputs for smooth functioning of plant
Effective production planning to avoid stoppage of machines and idling of manpower
Compliance of internal & External Audit related to Production Planning & Customer service activities
KEY ACHIEVEMENTS
Successful implementation Mckinsey & KPMG in production
Technology transfer and execution of new product and their compliance
Preparation of Qualification, SOP’s and master documents
Yield improvement of products & review of change over timing by idea generation
QMS evaluation & compliance of changes in facility, equipment & system
Handling of CAPA, Deviation, FMECA, Batch Failure, Market Complaint and APQR
Review of the QMS documents
Expansion of Manufacting and as well as Cipla Sikkim project
In Hetero expansion of Granulation, compression, coating and packing lines
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To assure that process validation, cleaning validation, packing validation, hold time study, performance verification, performance qualification and re-validations are properly planned, conducted and documented
Preparation and review of SOP’s related to the validation activities
To review the process variable impact assessment document, FMECA and Risk assessment documents
To perform the batch release and inspection lot generation, approval activities in SAP
Review of batch failure investigation and to provide adequate CAPA.

Summary

Overview

Work History

Sr Manager Production Manufacturing Packing PPIC

Manager

Dy Manager

Assistant Manager Production,PPIC,Audit Compliance

Education

H.S.E - Middle School Education

Associate of Science - Science Education

Bachelor of Science - Pharmaceutical Sciences

MBA - Operations Management

Skills

Additional Information

Accomplishments

Affiliations

Software

Certification

Interests

Work Availability

Quote

Timeline

Sr Manager Production Manufacturing Packing PPIC

Manager

Dy Manager

MBA - Operations Management

Assistant Manager Production,PPIC,Audit Compliance

Bachelor of Science - Pharmaceutical Sciences

Associate of Science - Science Education

H.S.E - Middle School Education

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