SANJAY KUMAR ROUT
Summary
Operations Leader with over 27 years of extensive experience in Manufacturing Operations within sterile pharmaceutical environments. Delivered high-volume production and maximised asset utilisation through effective production planning, packaging, and validation of injectables, including ophthalmic and oncology formulations. Focused on implementing quality systems and optimising resource planning to enhance overall production efficiency.
Overview
3
3
Languages
27
27
years of professional experience
Work History
Sr. GM Operation (Site Head)
Knovea Pharmaceutical Pvt. Ltd.
Indore, Madhya Pradesh
07.2021 - Current
- Oversaw production, warehouse, engineering, HR, admin, safety, procurement, and licensing activities within the plant.
- Established manufacturing, filling and packing processes for sterile injectable preparations (vials, PFS syringes and bag filling line).
- Led Greenfield project for sterile dual chamber vials, PFS, and bags, ensuring compliance with regulatory requirements.
- Executed projects on schedule, coordinating with vendors and planning FATs while updating project status to senior management.
- Qualified equipment, utilities and areas for operational compliance.
- Managed regulatory filings and conducted regulatory audits.
- Implementation of Aseptic Simulation Studies and Exhibit Batches of all developed products.
- Implemented strategies for product launch, focusing on market readiness and regulatory compliance.
- This facility is built for USFDA and EU GMP Regulatory requirements.
GM Operation (Operation Head)
Aurobindo Pharma Ltd.
Hyderabad
05.2020 - 06.2021
- Managed production, warehouse, qualification, and validation activities at Aurobindo Pharma Unit - IV, ensuring compliance with industry standards.
- Manufactured, filled and packed sterile injectable preparations, including liquid and lyophilised injectables (vials and ampoules), PFS syringes, ophthalmic products, blow-fill-seal products, complex injectables like microsphere products, and bag filling lines.
- Executed validation of equipment, processes, HVAC systems, water systems, compressed air systems, and performed media fills to ensure operational integrity.
- Production Planning, fabrication and dispatch of product according to the Schedule.
- Training conducted as per schedule regarding validation, safety & cGMP as per laid down standards. Preparing & updating Process validation procedures, Daily documents.
- The facility is US FDA and EU GMP, MHRA and WHO approved.
Sr. GM Operation (Operation Head)
Shilpa Medicare Ltd.
Hyderabad
10.2019 - 04.2020
- Managed the manufacturing, filling, and packing of sterile injectable preparations, including liquid, lyophilised injectable, and injectable powder.
- Managed cold chain product manufacturing, headspace requirements, and troubleshooting for new product establishment.
- Oversaw production, engineering, warehouse validation, projects, and technology transfer activities for oncology facility blocks.
- Executed the entire qualification and validation activities according to the validation plan.
- Modification of existing facilities for atomization and for regulatory compliance.
- Trained new works regarding machinery's productivity, discipline, safety & cGMP as per laid down standards.
- Transferred new products from F & D and executed their implementation.
- The facility is US FDA and EU GMP, MHRA and WHO approved.
Associate Director (Plant Head)
Dr. Reddy's Lab. Ltd.
Visakhapatnam, Andhra Pradesh
04.2018 - 09.2019
- Responsibility to handle the entire Production, warehouse, Engineering, Validation, Projects, HR & Admin, Purchase, Licensing and Technology transfer activities of Injectable Facility.
- Production Planning, Manufacturing, Filling, Packaging and dispatch of product according to the Schedule.
- Executed qualification and validation activities in alignment with project plan.
- Responsible for transferring new products from F & D and their execution.
- Executed projects, coordinating with vendors to implement facility upgrades.
- Trained new workers regarding machinery's productivity, discipline, safety & cGMP as per laid down standards.
GM (Plant Head)
Amneal Oncology Pvt. Ltd.
Hyderabad
04.2015 - 04.2018
- Oversaw production, planning, warehouse, engineering, HR and admin, safety, purchase and licensing activities for plant, projects, and technology transfer in oncology facility blocks.
- Managed manufacturing, filling, and packing of sterile injectable preparations, including liquid, lyophilised injectable, liposomal products, pre-fill syringes, and injectable powder.
- Production Planning, Manufacturing, Filling, Packaging and dispatch of product according to the Schedule.
- Handled cold chain product manufacturing, addressed Headspace requirements, and troubleshot to establish new product specifications.
- Executed qualification and validation activities per validation plan, ensuring compliance and quality standards.
- Led various expansion projects and coordinated with vendors for upgrades.
- Managed engineering activities related to processes, utilities, preventive maintenance, and calibration.
- Facilitated the transfer of new products from F&D and executed their implementation.
- Modification of existing facilities for atomisation and for regulatory compliance.
- Oversaw inventory management processes and the inventory control system.
Associate Director Production
Agila Ltd.
Bengaluru
09.2014 - 04.2015
- Managed all production activities for specialty formulation facility blocks to ensure effective operations.
- Production Planning, Manufacturing, Filling, Packaging and dispatch of product according to the Schedule.
- Manufactured, filled, and packed sterile injectable preparations, including both liquid and lyophilised forms.
- Trained new staff on machinery productivity, discipline, safety, and cGMP standards to maintain compliance.
- Coordinated various expansion projects and liaised with vendors for upgrades.
Senior Manager
Aurobindo Pharma Ltd.,
Hyderabad
06.2012 - 05.2014
- Responsible for Manufacturing, Filling and Packing of Sterile Injectable Preparation (Both Liquid and
Lyophilized Injectable (Vials and Ampoule), PFS Syringes, Ophthalmic, Blow-Fill-Seal, Complex
injectable like Microsphere products and Bag filling Line. - Trained new staff on machinery productivity, safety protocols, discipline, and cGMP compliance to enhance operational standards.
- Production Planning, fabrication and dispatch of product according to the Schedule.
- Involvement of validation of equipment, Process validation, HVAC system Validation, Water System
Validation, Compressed Air System Validation and Media Fill etc.
Manager Validation (A3)
Ranbaxy Lab. Ltd.
Paonta Sahib, Himachal Pradesh
05.2011 - 06.2012
- Managed qualification and validation activities across Ranbaxy Lab sites, ensuring compliance with regulatory requirements and guiding the validation team to meet cGMP upgrade timelines and management objectives.
- Executed validation of various equipment and systems, including process, computer system, HVAC, water, compressed air, and cleaning validations, ensuring adherence to regulatory standards.
- Execution of DQ, IQ, OQ and PQ of all equipment in all Blocks.
- Preparation, upgradation of Validation Master Plan. Planning for timely execution of re-validation of all equipment as per the Validation planner.
- Prepared protocols and reports for all validation programmes across equipment, areas, cleaning, and processes.
- Delivered training sessions on validation, safety, and cGMP for team members according to established schedules; prepared and updated process validation procedures and daily documentation.
Asst. Manager (Validation/Production)
Dabur Pharma Ltd.
Baddi, Himachal Pradesh
10.2006 - 03.2009
- Produced cytotoxic sterile injectable preparations, both liquid and lyophilised.
- Prepared protocols and executed validation programs for equipment, process, computer systems, HVAC systems, water systems, compressed air systems, and cleaning validation.
- Preparation of Product Dossier for Regulatory Submission.
- Production Planning, fabrication and dispatch of product according to the Schedule.
- Preparing & updating SOPs, Process validation procedures, Daily documents.
- Assisted in daily operations of the manufacturing department. familiar with day-to-Day work.
Executive (Quality Assurance)
Alkem Laboratories Ltd.
Baddi, Himachal Pradesh
08.2005 - 10.2006
- Managed equipment, utilities, cleaning, and process validation for dry powder injectable and OSD areas to maintain operational standards.
- Oversaw operations at India's largest pharma company, ensuring compliance with global regulatory bodies to uphold quality assurance standards.
- Delivered high level of service to customers in effort to build upon future relationships.
- Kept organisation in compliance with regulations and internal requirements.
- Formed and sustained strategic relationships with clients.
Management Staff (Production & Validation)
Cipla Ltd.
Goa
09.1999 - 08.2005
- Produced F.F.S Repulse, eye/ear drops, and nasal spray, ensuring compliance with regulatory standards.
- Prepared and updated standard operating procedures and process validation documents to ensure compliance with organisational standards.
- Trained new workers on machinery productivity, discipline, safety, and cGMP, fostering a culture of adherence to industry standards.
- Validated equipment including autoclaves, dry heat sterilizers, and mixing and filtration vessels, performing process validation, SIP, CIP validation, media fill, and area/equipment qualification to ensure operational integrity.
Education
B. Pharmacy -
Utkal University
Bhubaneswar01-2000
Graduation in Zoology (Hons.) -
Utkal University
Bhubaneswar01-1993
Skills
- Production planning
- Execution of Complex injectable manufacturing
- Oncology Products
- Ophthalmic and Nasal Spray Products
- BFS and Infusion technology
- Dual Chamber Vials, Bags and PFS products
- Project execution
- Vendor coordination
- Qualification and validation
- Regulatory audits
- Regulatory filings
- cGMP compliance
- Track wise
- SAP
- MS-Office
Languages Known
English
Hindi
Oriya
Custom
Seeking assignments in the areas of Operation in a growth-oriented Organization preferably in the pharmaceutical industry where high competence and skill is equally rewarded and provides opportunities for professional growth and simultaneous learning.
Timeline
Sr. GM Operation (Site Head)
Knovea Pharmaceutical Pvt. Ltd.
07.2021 - Current
GM Operation (Operation Head)
Aurobindo Pharma Ltd.
05.2020 - 06.2021
Sr. GM Operation (Operation Head)
Shilpa Medicare Ltd.
10.2019 - 04.2020
Associate Director (Plant Head)
Dr. Reddy's Lab. Ltd.
04.2018 - 09.2019
GM (Plant Head)
Amneal Oncology Pvt. Ltd.
04.2015 - 04.2018
Associate Director Production
Agila Ltd.
09.2014 - 04.2015
Senior Manager
Aurobindo Pharma Ltd.,
06.2012 - 05.2014
Manager Validation (A3)
Ranbaxy Lab. Ltd.
05.2011 - 06.2012
Asst. Manager (Validation/Production)
Dabur Pharma Ltd.
10.2006 - 03.2009
Executive (Quality Assurance)
Alkem Laboratories Ltd.
08.2005 - 10.2006
Management Staff (Production & Validation)
Cipla Ltd.
09.1999 - 08.2005
B. Pharmacy -
Utkal University
Graduation in Zoology (Hons.) -
Utkal University