Summary
Overview
Work History
Education
Skills
Performance Spectrum
Languages
Personal Information
Affiliations
Disclaimer
Timeline
Generic

Manoj Kumar Mohanty

Hyderabad

Summary

Dynamic Production Specialist with extensive experience at Dr. Reddy's Lab, excelling in equipment qualification and project management. Proven track record in risk assessment and SOP development, driving continuous improvement initiatives. Adept at vendor assessment and production scheduling, ensuring timely project delivery while fostering collaboration across teams.

Overview

11
11
years of professional experience

Work History

Production Specialist-V4

Dr.reddys Lab
Hyderabad
01.2022 - Current
  • Preparation of process order and BOM in SAP.
  • Batch posting and release on SAP.
  • Monitoring and planning of visual inspection of vials and PFS.
  • Responsible for the new equipment qualification.
  • Vendor assessment for new equipment procurement.
  • SME for packaging and Visual inspection.
  • Handling end to end project of Cat 3 & Cat 4 System as per GAMP 5 categorization.
  • Timely and quality delivery of project deliverables in accordance with the project’s schedule and timeline under the direction of the project manager.
  • Handling the projects like Equipment upgradation and new equipment installation and Qualification.
  • Review with vendor and Preparation of URS and other Qualification documents.
  • Preparation, execution & review of validation documents like risk assessment, validation plan, URS, FRS, Qualification Scripts (FAT, SAT, DQ, IQ, OQ, PQ), Test Protocols and reports, Traceability matrix and validation report with release Note.
  • Preparation of GxP assessment and System classification checklist for different Systems.
  • Gap assessment and preparation of QRA document.
  • Good knowledge in GAMP, 21 CFR part 11 guidelines.
  • Initiation of Change control and Incident through SAP.
  • Having adequate knowledge and understanding on change management and Change control procedures, Deviation handling, and CAPA management through SAP and DOCHUB.
  • Preparation and Review of SOP.
  • Effectiveness check verification of Implemented CAPA’s.
  • Knowledge in the concepts of L1 to L4 structures of track and trace System.
  • Co-ordinating with SAP ATTP team for Track and trace system.
  • MBR design through werum PAS -X.

Senior Executive

Strides Pharma Limited
Bangalore
03.2016 - 01.2022
  • Company Overview: Strides pharma limited is an USFDA & MHRA approved plant, exporting products to US, Europe & ROW market, which has facilities for Solid, Semisolid & soft gel preparation.
  • Monitoring of production activity for qualitative & quantitative.
  • GMP compliance, preparing for audits, implementing GMP norms, GMP documents review & updating compliance of any newly adopted system.
  • Manage human and material resources to meet production targets.
  • Make decisions about equipment use, maintenance, modification and procurement.
  • Work out and implement standard operating procedures for production operations.
  • Implement cost control programs.
  • Ensure efficient collaboration and co-ordination between relevant departments including procurement, distribution and management.
  • Equipment monitoring - keeping a check on equipment performance, preventing maintenance for better utilization, using vacant for production, suggesting for upgradation.
  • Handling of change control and Deviation process management with operation process.
  • Implement GMP through Quality Management System.
  • Planning, coordinating & procuring materials requirement for manufacturing and packing & shop floor planning for material issue, receipt & release.
  • Co-ordination with PDC for art work preparation, providing the dimension & review of art work.
  • Ensure implementation of CAPA given for non-conformances, market compliant, incident or deviation.
  • To maintain quality norms, standards & practices during material movement & storage.
  • Training to new employee and refresher training to old employee.
  • Strides pharma limited is an USFDA & MHRA approved plant, exporting products to US, Europe & ROW market, which has facilities for Solid, Semisolid & soft gel preparation.

Executive

Biocon Ltd.
01.2015 - 03.2016
  • Company Overview: Biocon an USFDA & MHRA approved plant, exporting products to US, Europe & ROW market, which has facilities for injectable preparation.
  • Biocon an USFDA & MHRA approved plant, exporting products to US, Europe & ROW market, which has facilities for injectable preparation.

Production Trainee Officer

Medopharm Pvt. Ltd
Chennai
02.2014 - 01.2015
  • Company Overview: Medopharm pvt.ltd. a WHO & MHRA approved plant, manufacture drugs for top branded companies.
  • Medopharm pvt.ltd. a WHO & MHRA approved plant, manufacture drugs for top branded companies.

Education

Msc - Biotech

Singhania University
Rajasthan
01.2021

B. Pharmacy -

Biju Patnaik University
ODISHA
01.2010

Skills

  • Equipment qualification
  • Project management
  • Risk assessment
  • Continuous improvement
  • SOP development
  • Vendor assessment
  • Production scheduling
  • Product packing
  • Valgenesis
  • DOC HUB
  • SAP
  • MS Suite

Performance Spectrum

  • Pack size harmonization for packing section in order to maintain less inventory and productivity improvement.
  • Worked closely with the business and project team members to evaluate business needs, defining and prioritizing requirements and agreeing process flows and analytical capabilities that align wherever possible with leading practice business processes.
  • Successfully faced USFDA and MHRA audit without any non-compliance.
  • Got best Team player award at Strides.
  • Got highest output achievement award in a single shift with certification.
  • Working as a team player with strong communication, analytical and problem-solving skills.
  • Proficiency at grasping new technical concepts quickly, utilizing the same in productive manner within the stipulated time.
  • Awarded for Jekson track and trace project for on time delivery.

Languages

  • English
  • Hindi
  • Oriya
  • Kanada

Personal Information

  • Date of Birth: 07/16/89
  • Nationality: Indian

Affiliations

  • Playing Cricket
  • Reading

Disclaimer

The Information furnished above is true to the best of my knowledge and I will take the complete responsibility in case of any circumstances.

Timeline

Production Specialist-V4

Dr.reddys Lab
01.2022 - Current

Senior Executive

Strides Pharma Limited
03.2016 - 01.2022

Executive

Biocon Ltd.
01.2015 - 03.2016

Production Trainee Officer

Medopharm Pvt. Ltd
02.2014 - 01.2015

Msc - Biotech

Singhania University

B. Pharmacy -

Biju Patnaik University
Manoj Kumar Mohanty