DR.RANA PRATAP SINGH
Haridwar
Work Preference
Summary
▪ Diligent Approved Manufacturing Chemist (Injection-SVP), professionally & technically competent in all aspects of the Parenteral Production (LVP/SVP/Biological Products), Operations, Technology Transfer, Green Field Projects with an experience of 17.0+ years in the industry; currently spearheading efforts with Macin Remedies India Ltd., Moga, Punjab as GM - Operations (Plant Head).
▪ Having sound knowledge of Product Development,Technology Transfer, Green Field Projects, Process Validation, Autoclave Validation, Tunnel Validation, Media Fill (Process Simulation), Area Qualification, and other related activities.
▪ Having sound knowledge of GMP/GLP practices across the plant with respect to Pharmaceutical Quality System. Well versed with QMS, Deviation Handling, Change Control, OOS/OOT, CAPA, Data Integrity, Risk Management, Contamination Control Strategy, Stability Studies, Training, Vendor Qualification etc.
▪ Expertise in Layout improvement, Quality Audits of Facility as per Regulatory norms (Gap Assessment with respect to Regulatory norms and accordingly CAPA planner as improvement planner to make facility Audit ready).
▪ Expertise in Project Progress Regulation by day-to-day improvement /task completion as per Master Planner by Gantt Chart.
▪ Well versed with Operational Excellence philosophy, implemented Tier Reporting System, Kaizen, Cost Saving Projects, KRA/KPI & Goal setting, Lean management& Motion Study.
Overview
18
18
years of professional experience
Work History
GM- Operations: Plant Head (SVP: Project)
MACIN REMEDIES INDIA LTD.
04.2024 - Current
- Overall responsible for Plant Operations including Project (Green Field)
- Responsible for day-to-day development with respect to SVP (Green Field Project)
- Preparation of Ghant Chart to track all related activities, i.e., Commissioning, Qualification & Validation for fruitful utilization of resources
- Preparation of BOM (SVP) to initiate Material Procurement (RM/PM) and further preparation of Registration samples & Dossier filling to initiate commercial production
- To monitor and supervise timely preparation of documents as SOP/ Qualification & Validation documents and provide guidance to complete the task
- Ensure all products are formulated, prepared, and tested in accordance with the policies & procedures, compendia and other legal and professional standards and guidelines relating to cGMP.
- Review and verify Documentation of all manufacturing activities (BMR, Calibration formats, Log Books, Validation protocols) and Packing activities.
- Preparing various Reports as Daily Production Report, Monthly Production Report, MRM (Management Review Meeting) to facilitate decision making and fruitful dissemination of information.
- Review and verify quality checking at various stages and implementing proper online system.
- Overall responsible for Qualification and Validation activities within timelines.
- Monitoring of various process to achieve the cost reduction wherever possible with best quality.
- Responsible for Daily Progress at Facility as per schedule.
- Monitoring of various process to achieve targeted production and mitigation of Process Bottle-necks.
GM- Operations: Plant Head (BFS/FFS(LVP); Vaccine & SVP: Project)
ATLANTIC LIFESCIENCES LTD.
07.2023 - 03.2024
- Overall responsible for Plant Operations including Large Volume Parenteral (BFS/FFS), Vaccine & SVP
- Responsible for day-to-day development with respect to Vaccine & SVP (Green Field Project)
- Preparation of Ghant Chart to track all related activities, i.e., Commissioning, Qualification & Validation for fruitful utilization of resources
- Preparation of BOM (SVP) to initiate Material Procurement (RM/PM) and further preparation of Registration samples & Dossier filling to initiate commercial production
- To monitor and supervise timely preparation of documents as SOP/ Qualification & Validation documents and provide guidance to complete the task
- Responsible for Monthly & day to day planning for LVP (BFS/FFS) to ensure market demands and effective utilization of all available resources.
- Ensure all products are formulated, prepared, and tested in accordance with the policies & procedures, compendia and other legal and professional standards and guidelines relating to cGMP.
- Review and verify Documentation of all manufacturing activities (BMR, Calibration formats, Log Books, Validation protocols) and Packing activities.
- Preparing various Reports as Daily Production Report, Monthly Production Report, MRM (Management Review Meeting) to facilitate decision making and fruitful dissemination of information.
- Review and verify quality checking at various stages and implementing proper online system in Production activities.
- Overall responsible for Qualification and Validation activities at Production floor within timelines.
- Monitoring of various process to achieve the cost reduction wherever possible with best quality.
- Overall responsible for day-to-day Production activities following cGMP Guidelines
- Responsible for Daily Progress at Facility as per schedule.
- Monitoring of various process to achieve targeted production and mitigation of Process Bottle-necks.
- Participated in development of more than 20 SVP products (in Ampoule), 10 + Ophthalmic products, 2 LVP products along with Lyophilization Cycle recipe establishment for ready to fill Snake Venom Antiserum(African) first time in Ghana.
- Also taken 20+ registration batches in SVP/Ophthalmic/LVP/Biological Section within record time and all products are going to be manufactured first time locally in Ghana.
DGM-Production: Plant Head (Liquid Injectable: Insulin Products/DPI/OSD)
M. J. BIOPHARM PVT. LTD.
06.2020 - 06.2023
- Overall responsible for Plant Operations including Liquid Injectables, DPI and OSD.
- Ensure all products are formulated, prepared, and tested in accordance with the policies & procedures, compendia and other legal and professional standards and guidelines relating to cGMP.
- Review and verify Documentation of all manufacturing activities (BMR, Calibration formats, Log Books, Validation protocols) and Packing activities.
- Responsible for Daily & Monthly Planning as per Production Plan.
- Preparing various Reports as Daily Production Report, Monthly Production Report, MRM (Management Review Meeting) to facilitate decision making and fruitful dissemination of information.
- Review and verify quality checking at various stages and implementing proper online system in Production activities.
- Overall responsible for Qualification and Validation activities at Production floor within timelines.
- Monitoring of various process to achieve the cost reduction wherever possible with best quality.
- Overall responsible for day-to-day Production activities following cGMP Guidelines.
- Managing Documentation throughout the Department (BMR & BPR, Calibration formats, Log-Books, Validation protocols).
- Overall responsible for Manufacturing and filling operations of parenteral products (in vials/cartridge/PFS/Ampoule and DPI) and OSD (Tablet & Capsule) following cGMP Guidelines, monitoring and maintenance of Sterile, Supporting & Packing Areas.
- Responsible for Daily Progress in Production as per schedule.
- Additionally responsible for LL site (Epygen Biotech.): Greenfield project.
- Monitoring of various process to achieve targeted production and mitigation of Process Bottle-necks.
Dy. Manager- Technology Transfer (Production: SVP/LVP)
AKUMS DRUGS & PHARMACEUTICALS LTD.
12.2015 - 05.2020
- Responsible for complete technology transfer of products from R&D and from outside sources (P2P or LL) which includes documents review, TC/VC with BD team along with customer for product queries, confirmation for product feasibility with Production and QC, arrangement for analytical technology transfer, initiation for optimization batches/process validation batches with cross functional team.
- Responsible for Placebo preparation as required in QC and Stability.
- Trouble shooting of products manufacturing in facility with R&D.
- Batch preparation for new Vendor development.
- Preparation of RM BOM of new technology transfer products along with revision of RM BOM.
- Arrangement of Market Samples required to carry out various Plant activities.
- Arrangement of samples/Batch manufacturing for Registration Samples.
- Preparing various Reports as daily production reports, Qualification & Validation Protocol /Reports to facilitate decision making and fruitful dissemination of information.
Asst. Manager – Production
NITIN LIFE SCIENCES LTD.
12.2013 - 12.2015
- Worked from Project Level (Green Field) to Operational Level.
- Responsible for Daily & Monthly Planning as per Production Plan.
- Ensure all products are formulated and prepared in accordance with the policies & procedures, compendia and other legal and professional standards and guidelines relating to cGMP.
- Monitoring of various process to achieve the cost reduction where ever possible with best quality.
- Managing Documentation throughout the Department (BMR & BPR, Calibration formats, Log Books, Validation protocols).
- Reviewing of production related SOPs, BMR & BPR. Handling process, quality checking at various stages and implementing proper online system in Production activities.
- Manufacturing and filling operations of parenteral products (in vials). Following WHO/ cGMP Guidelines, monitoring and maintenance of sterile, supporting & Packing Areas.
- Preparing various Reports as daily production reports and Monthly Production Report to facilitate decision making and fruitful dissemination of information.
Sr. Executive-Production (Injectable—SVP: Narcotic Products)
RUSAN PHARMA LTD.
04.2013 - 12.2013
- Responsible to develop, verify and maintain the computerized product formulation database to ensure accuracy and completeness of all derived formulae.
- Supervising and participating in the formulation, preparation and provision of sterile pharmaceutical products (Ampoule, Pre filled Injector, Lyophilizer).
- Managing Documentation throughout the Department (BMR & BPR, Calibration formats, Log Books, Validation protocols).
- Reviewing of production related SOPs, BMR & BPR. Handling process, quality checking at various stages and implementing proper online system in Production activities.
- Manufacturing and filling operations of parenteral products (SVP). Following WHO/ cGMP Guidelines, monitoring and maintenance of sterile, supporting & Packing Areas.
- Preparing various Reports as daily production reports and Monthly Production Report to facilitate decision making and fruitful dissemination of information.
Sr. Officer (InjectablesSVP)
THEMIS MEDICARE LTD.
12.2010 - 04.2013
- Responsible to develop, verify and maintain the computerized product formulation database to ensure accuracy and completeness of all derived formulae.
- Supervising and participating in the formulation, preparation and provision of sterile pharmaceutical products.
- Ensure all products are formulated, prepared and tested in accordance with the policies & procedures, compendia and other legal and professional standards and guidelines relating to cGMP.
- Managing Documentation of all manufacturing activities (BMR, Calibration formats, Log Books, Validation protocols).
- Reviewing of production related SOPs, Process Validation, preparation of related documents and BMR. Handling process, quality checking at various stages and implementing proper online system in Production activities.
- Manufacturing and filling operations of parenteral products (SVP). Following WHO/cGMP Guidelines, monitoring and maintenance of sterile & supporting areas.
- Preparing various Reports as daily production reports and Monthly Production Report to facilitate decision making and fruitful dissemination of information.
Officer – Production (BFS- LVP & SVP)
EUROLIFE HEALTHCARE PVT. LTD.
12.2007 - 12.2010
- Planned and executed complete Manufacturing and Filling operations of sterile products.
- Ensured development, maintenance and enforcement of policies and procedures to comply with the standards of practice of cGMP as set out in an enactment or a professional standard adopted by the Organization.
- Involved in Batch Manufacturing and aseptic filling in LVP and SVP, In Process Quality Control (IPQC) and Environmental monitoring of sterile and classified area.
- Handled documentation according to cGMP and WHO Guidelines, Filter Integrity Machine (Sartorius) and prepared SOP, BMR and other documents.
Education
Ph.D. - Pharmaceutical Sciences
Bhagwant University
Ajmer, Raj., India01.2012
M. Pharm -
Rajiv Gandhi University of Health Sciences
Bangalore, India01.2007
B. Pharm - undefined
Rajiv Gandhi University of Health Sciences
Mandya, India01.2005
Skills
- Operational Production Management
- Technical Documentation
- Compliance Audit
- Management Information Systems
- Green Field Project Management
- Technology Transfer
- Quality Management
- Process Optimization
- Workforce Management
- Operational Excellence
- Product Development
- Continuous Improvement Methodology
- Cost Reduction Initiatives
- Waste Reduction
- Motion Study
- Qualification/Validation
- Resource Planning/Optimization
- KRA/KPI & Goal Setting
- OEE
- Proficient in Microsoft Office, SAP/ERP with Internet Applications
AUDIT FACED
WHO(PQ)
FDA /MOH (UKRAINE, KENYA, UGANDA & RUSSIA)
PIC’S
ANVISA
SAHPRA/MCC
EUGMP, FDB (GHANA)
EFDA (ETHIOPIA)
Languages
English
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Certification
Approved Manufacturing Chemist in SVP(Small Volume Parenterals)from Drug Authority India
Quote
I can’t understand why people are frightened of new ideas. I’m frightened of the old ones.
John Cage
Interests
Doing Exercise , Yoga & Meditation
Timeline
GM- Operations: Plant Head (SVP: Project)
MACIN REMEDIES INDIA LTD.
04.2024 - Current
GM- Operations: Plant Head (BFS/FFS(LVP); Vaccine & SVP: Project)
ATLANTIC LIFESCIENCES LTD.
07.2023 - 03.2024
DGM-Production: Plant Head (Liquid Injectable: Insulin Products/DPI/OSD)
M. J. BIOPHARM PVT. LTD.
06.2020 - 06.2023
Dy. Manager- Technology Transfer (Production: SVP/LVP)
AKUMS DRUGS & PHARMACEUTICALS LTD.
12.2015 - 05.2020
Asst. Manager – Production
NITIN LIFE SCIENCES LTD.
12.2013 - 12.2015
Sr. Executive-Production (Injectable—SVP: Narcotic Products)
RUSAN PHARMA LTD.
04.2013 - 12.2013
Sr. Officer (InjectablesSVP)
THEMIS MEDICARE LTD.
12.2010 - 04.2013
Officer – Production (BFS- LVP & SVP)
EUROLIFE HEALTHCARE PVT. LTD.
12.2007 - 12.2010
B. Pharm - undefined
Rajiv Gandhi University of Health Sciences
Ph.D. - Pharmaceutical Sciences
Bhagwant University
M. Pharm -
Rajiv Gandhi University of Health Sciences