Summary
Overview
Work History
Education
Skills
Websites
Certification
Accomplishments
Languages
Timeline
Generic
Arun Kumar Das

Arun Kumar Das

Dehradun

Summary

Highly accomplished and results-driven AGM with 21 years of experience in sterile injectable manufacturing operation and compliance. Proven track record in leading cross-functional teams, optimizing production processes, and ensuring regulatory compliance. Skilled in implementing quality control measures, driving operational efficiency, and achieving cost reduction targets. Strong knowledge of cGMP guidelines, FDA regulations, and industry best practices. Adept at developing and implementing strategic plans to meet organizational goals. Excellent leadership, communication, and problem-solving abilities. Committed to delivering exceptional results and driving continuous improvement in manufacturing operations.

Overview

21
21
years of professional experience
1
1
Certification

Work History

Production Head AGM

Fresenius Kabi Oncology Limited
Baddi
07.2024 - Current
  • Provided technical advice regarding equipment specifications or usage issues as needed for optimal operational efficiency in Oncology Product Manufacturing,packaging and aseptic filling.
  • Organized regular meetings with team members to discuss progress, identify problems and devise solutions.
  • Scheduled staff work assignments, rotations and overtime.
  • Aided raw material planning and escalated supplier issues, preventing shortages.
  • Collaborated with engineering teams to design processes that meet quality requirements while minimizing costs and timeframes.
  • Prepared operations data to produce comprehensive reports to management.
  • Collaborated with leadership to develop production department budget and forecast.
  • Determined budgets, production goals and rates based on company policies and requirements.
  • Ensured adherence to company policies and regulations related to safety, environment protection and legal compliance matters.
  • Conferred with management and subordinates to resolve problems or complaints.
  • Worked effectively in team environments to make the workplace more productive.

AGM Manufacturing

Intas Pharmaceutical Ltd.
Dehradun
03.2021 - 07.2024
  • Oversee and manage daily operations, ensuring compliance with policies and procedures
    Develop and implement strategic plans and initiatives to achieve organizational goals and objectives
    Collaborate with other departments and teams to achieve cross-functional goals
    Ensure compliance with legal and regulatory requirements
    Conduct risk assessments and develop risk management strategies
    Lead and supervise a team of employees, providing guidance and support
    Manage department budget and allocate resources effectively
    Monitor and evaluate department performance and make recommendations for improvement
    Stay up-to-date with industry trends and best practices to drive innovation and continuous improvement
    Develop and implement strategic plans and initiatives to achieve organizational goals
    Participate in industry conferences and seminars to stay current on best practices and emerging trends in compliance
    Monitor and analyze data to identify trends and areas for improvement in compliance efforts

Senior Manager Manufacturing

Intas Pharmaceutical Ltd.
Dehradun
08.2018 - 03.2021

New Sterile Facility Erection and Commissioning intended for export to US and Europecomprises of Lyophilized,Liquid Injectable Dosage form in Vial and PFS pack sizes .

Manager

Mankind Pharma
Ponta Sahib
06.2017 - 07.2018
  • New Sterile Facility Erection and Commissioning intended for export to US comprises of Liquid Injectable Dosage form in Vial, ampoule and respule pack sizes .

Asst Manager Manufacturing

Wockhardt Pharma Ltd
Aurangabad
06.2015 - 07.2017
  • Section Head for Fill Finish line of Insulin in Vial,Cartridge.
  • Lyophilized injection manufacturing and filling.
  • Liquid injectable filling in PFS.

Asst Manager

Intas Pharmaceutical Ltd
Ahmedabad
12.2014 - 05.2015
  • Section Head for Lyophilized Injectable Manufacturing and Filling.

Dy.Manager

Akums Drugs and Pharmaceutical ltd
Haridwar
10.2013 - 11.2014
  • Production Head for Liquid Fill-Finish Facility, FFS, and BFS Fill Finish Injection Facility.

Sr.Executive

Aurobindo Pharma
Hydrabad
07.2009 - 09.2013
  • Validation.

Executive

Nicholas Piramal Healthcare ltd
Pithampur Indore
01.2008 - 05.2009
  • Manufacturing of Sterile Eye Dosage Forms.

Officer

German Remedies/ Zydus Cadila
Goa
05.2004 - 11.2007
  • Manufacturing, filling and packing of Injectable.

Education

B.pharmacy - Pharmaceutical Chemistry,Pharmaceutics,Pharmacology,Pharmajuruspodence,Pharmacogonosy

Utkal
Bhuveneshawar, India
04.2004

+2 Intermediate - Physics,Chemistry,Biology, English,Sanskrit

CBSE
BOKARO STEEL CITY, India
04.1997

10th - Maths,Science,SSt, English,Hindi

CBSE
BOKARO STEEL CITY, India
04.1994

Skills

  • Manufacturing Operations and Compliance
  • Planning and Delivery Management
  • Quality management
  • Production Compliance
  • System conflict management
  • Team building and leadership
  • Sterile injectable manufacturing operations
  • Aseptic processing systems
  • Cleanrooms
  • Detail-oriented
  • Documentation review
  • Problem-solving
  • Decision-making
  • High-pressure situations
  • Team management
  • Production efficiency
  • Manufacturing processes oversight
  • Regulatory compliance
  • FDA
  • GMP
  • Process improvement

Certification

  • LSSGB
  • LSSBB
  • Quality Management for Operational Excellence
  • Speaking Confidently and Effectively

Accomplishments

  • 8 times faced FDA Audits out of which 6 time Audit cleared with zero 483.
  • 5 times lead MHRA Inspection successfully.

Languages

English, Advanced (C1)

Timeline

Production Head AGM

Fresenius Kabi Oncology Limited
07.2024 - Current

AGM Manufacturing

Intas Pharmaceutical Ltd.
03.2021 - 07.2024

Senior Manager Manufacturing

Intas Pharmaceutical Ltd.
08.2018 - 03.2021

Manager

Mankind Pharma
06.2017 - 07.2018

Asst Manager Manufacturing

Wockhardt Pharma Ltd
06.2015 - 07.2017

Asst Manager

Intas Pharmaceutical Ltd
12.2014 - 05.2015

Dy.Manager

Akums Drugs and Pharmaceutical ltd
10.2013 - 11.2014

Sr.Executive

Aurobindo Pharma
07.2009 - 09.2013

Executive

Nicholas Piramal Healthcare ltd
01.2008 - 05.2009

Officer

German Remedies/ Zydus Cadila
05.2004 - 11.2007
  • LSSGB
  • LSSBB
  • Quality Management for Operational Excellence
  • Speaking Confidently and Effectively

B.pharmacy - Pharmaceutical Chemistry,Pharmaceutics,Pharmacology,Pharmajuruspodence,Pharmacogonosy

Utkal

+2 Intermediate - Physics,Chemistry,Biology, English,Sanskrit

CBSE

10th - Maths,Science,SSt, English,Hindi

CBSE
Arun Kumar Das