Satyander Thakur
Dy. Manager
Paonta Sahib,Himachal Pradesh
Summary
Production Manager manages sterile manufacturing performance across aseptic filling, documentation review, and routine qualification by executing 3–5 production plans per week to keep output aligned with plan. Connects production, QA, QC, engineering, and stores to resolve issues quickly and maintain controlled operations. Brings discipline to training, inventory tracking, and compliance follow-up across the production floor.
Overview
4
4
Languages
1
1
Certification
17
17
years of professional experience
Work History
Deputy Manager in Production
Biological E. Ltd.
12.2020 - Current
- Block Lead with a team of approximately 40 personnel in dry powder production line operations. Managed daily activities to ensure efficient workflow and adherence to quality standards. Streamlined processes to enhance productivity within the production department. Coordinated training programs for team members to improve skills and performance.
- To perform change control, manufacturing investigation related to Out of specification (OOS), OOL, OOT, Market complaint & ADE, Deviations and CAPAs.
- Responsible for support and closure of QMS operations and Regulatory observations and internal audit compliance.
- Coordinate, attend and lead the internal meetings with CFT Micro Dept./Store/Engineering/QA/QC for smooth daily production activity
- Planning and managing all daily routine activity which is required for smooth production activity as per plan
- Preparation and implementation of GMP related documents
- Monitoring of cGMP aspects in shop-floor, online completion of batch records and GMP records and their review.
- Responsible for planning and coordination of routine/periodic qualification of equipments of production department.
- Certified Trainer & Department Training coordinator for production department and to provide training related to awareness, observation and related to revised procedure.
Sr. Executive in Production Department
Mankind Pharma Pvt. Ltd
12.2018 - 07.2020
- Working as Sr. Executive in Production Injection Department.
- Primary functions are QMS operations and Regulatory point’s and internal audit compliance and secondary function are production operation.
- Coordinate, attend and lead the internal meetings with Store/Engineering/QA/QC for smooth daily production activity.
- Planning and managing all daily activity which is required for smooth production activity.
- Support in change control, manufacturing investigation related to Out of specification (OOS), Deviations and CAPA.
- Preparation and implementation of GMP related documents
- Monitoring of cGMP aspects in shop-floor, online completion of batch records and GMP records.
- Responsible for planning and coordination of routine qualification of equipments manufacturing department.
Sr. Executive in Production Department
Pfizer Healthcare India Pvt. Ltd.
05.2017 - 12.2018
- Worked as shift lead for manufacturing area, component preparation area, vial washing and depyrogenation area and aseptic filling area.
- Leading a team of around 15 staff (Sr. Executive / Executive / Associates / Trainees / Operators).
- Coordinate, attend and lead the internal meetings with Store/Engineering/QA/QC for smooth daily production activity.
- Planning and managing all daily activity which is required for smooth production activity.
- Ensures manufacturing targets completed on time, on-schedule and within budget.
- Responsible for coordination & planning with validation department for routine qualification of Equipment.
- Responsible for Planning & execution of exhibit batches with coordination of Formulation development & technology transfer Department.
- Responsible for Preparation & revision of SOP using Documentum software.
- Responsible to support for investigation of incidents.
- Reporting to Line Manager - Production in matter of personnel allocation, delivery dates & analyzing various issues.
Sr. Executive in Production Department
Mylan Laboratories Ltd, Bangalore (Oncology)
01.2016 - 04.2017
- Worked as Sr. Executive in Production for Aseptic area, Manufacturing & Autoclave Section.
- Leading a team (Officer /Supervisor/Trainees).
- Coordinate, attend and lead the internal meetings with Store/Engineering/QA/QC for smooth daily production activity.
- Planning and managing all daily activity which is required for smooth production activity.
- Ensures manufacturing targets completed on time, on-schedule and within budget.
- Supervises and mentors team members and ensures team members understand objectives, deliverables, timelines and tasks.
- Responsible to support for Investigation.
- Responsible for area monitoring.
- Responsible for online completion , reconciliation and submission of BMR.
- Responsible for Routine qualification of HVAC & Equipment’s of production department.
Sr. Executive in Production Department
Rusan Pharma Ltd.
07.2015 - 12.2015
- Manufacturing of Narcotic products like-Nalbuphine,Sodium PAS, morphine.
- PFS , Ampoule filling and sealing area and Vial Filling area inspection and line clearance during product change over in the area.
- Supervision of Vial washing and tunnel depyrogenation area, component preparation area, manufacturing area and aseptic filling area during batch processing.
- Responsible for Production planning as per the marketing requirement.
- Handling of Change controls / Deviations / Incidents / other issue related to the process & reporting to Asst. manager.
- Support to packing area in packing of Vials / Cartridges / PFS as per marketing priorities.
- BMR, BPR & Logbook Review.
- Preparation of SOP’s & their implementation.
Sr. Officer in Production Department
Akorn India Pvt. Ltd.
05.2012 - 04.2015
- Filling area inspection and line clearance during product change over in area.
- Monitoring of Routine qualification of filling machine, HVAC system and other filling area related equipments.
- Supervision of Batch filling operation as per respective standard operating procedures & Batch Manufacturing Records.
- Responsible for the completion of the daily output & allocate the manpower as per requirement & in a proper shift to get required output.
- Responsible for day-to-day activity going on shop floor.
- Responsible for day to day environmental monitoring.
- Responsible for balance calibration, ampoule and vial terminal sterilization.
- Conducting machine trial.
- Preparation of SOP’s.
Pharmacist in Production Department
Zuventus Healthcare Limited
02.2011 - 04.2012
- Filling area inspection and line clearance during product change over in area.
- Monitoring of Routine qualification of filling machine, HVAC system and other filling area related equipments.
- Supervision of Batch filling operation as per respective standard operating procedures & Batch Manufacturing Records.
- Responsible for the completion of the daily output & allocate the manpower as per requirement & in a proper shift to get required output.
- Responsible for day-to-day activity going on shop floor.
- Responsible for day to day environmental monitoring.
- Responsible for balance calibration, blending of batch for dry powder (API).
Asst. Officer in Production Department
Mankind Pharma Pvt Ltd.
08.2009 - 07.2010
- Filling area inspection and line clearance during product change over in area.
- Monitoring of Routine qualification of filling machine, HVAC system and other filling area related equipments.
- Supervision of Batch filling operation as per respective standard operating procedures & Batch Manufacturing Records.
- Responsible for the completion of the daily output & allocate the manpower as per requirement & in a proper shift to get required output.
- Responsible for day-to-day activity going on shop floor.
- Responsible for day to day environmental monitoring.
- Responsible for balance calibration, Blending of batch for dry powder (API).
Education
MBA - undefined
Vinayaka Mission University
01-2010
B. Pharmacy - undefined
A.S.B.A.S.J.S. Memorial college of Pharmacy
Bela Punjab01-2008
12th (Non-Medical Science) - undefined
HPBSE-Dharamshala
Paonta Sahib01-2003
10th - undefined
HPBSE-Dharamshala
Jakhana01-2001
Skills
GMP document control
Batch record review
Aseptic filling operations
Production planning
Equipment qualification coordination
Deviation management
CAPA management
Change control
OOS investigation
Internal audit compliance
Process validation
Cleaning validation
GxP compliance
Regulatory inspections
Quality management system
Root cause analysis
Manufacturing execution system
Environmental monitoring qualification
Material release
Technology transfer
Training matrix management
Key Achievements
- Key Achievements, Biological E. Ltd.
- Lead the area and block and actively participated in project work for block and facility.
- To achieve the given production plan within the stipulated timeline as give by the management.
- Modification of Filling machine and area for smooth working and reduce the machine rejection.
- Actively participated in Media Fill, Exhibit batches and commercial batches.
- Procedure for handling of aseptic area garments, cleaning of critical area and non-critical area revised for simplification revised for simplification.
- Saving of cost more than 20 lacks in project and reduces the delay time by simplifying the process and procedures.
- Developing the alternate vendor for all critical consumables.
- Key Achievements, Mankind Pharma Pvt. Ltd.
- Procedure for handling of aseptic area garments revised for simplification.
- Procedure for cleaning of critical area and non-critical area revised for simplification.
- Procedure for Entry and Exit to Clean area and Aseptic and to production area revised for simplification
- Actively participated in project for log book reduction. (Around 80 logbook reduced).
- Audit faced and work for identified gap and their analysis and part of internal self inspection team and compliance to external audit-Mr.Robb Walker & Mr. Daniel and MS Parul Patel-Ex.FDA Inspector.
- Key Achievements, Pfizer Healthcare India Pvt. Ltd.
- Successfully completed the USFDA approval of facility after receiving the 83 observations.
- Increased numbers of garments per load results in reduction of total loads required for batch.
- Increased numbers of glove ports per load results in reduction of total loads required for batch.
- Intervention project for open door and closed door.
- Cycle development in autoclave.
- Introduction of the integrity and sterilization of 0.22 micron vent filters for filling and stoppering machine.
- CI (Continous Improvement) champion for Cepha- Block lead.
- Key Achievements, Mylan Laboratories Ltd, Bangalore (Oncology)
- Worked with project team and got successfully USFDA approval.
- Media Fill participation.
- SME for Aseptic area For suite-1 for Oncology.
AUDIT EXPOSURE:
- Audit
- US- FDA 2013 Ms. Parul Patel
- US-FDA 2013 Mr. Peter Baker
- US-FDA 2017 Dr. Barbosa Mr. Melendez
- US- FDA 2018 Mr. Jose. E Melendez Mr. Ademola O Daramola
- US- FDA 2023 Ms. Patty P Kaewussdangkal
- Consultant (FDA) 2019 Ms. Parul Patel
- Consultant (FDA) 2019 Mr. Robb Walker
- Consultant (FDA) 2020 Mr. Daniel
- Consultant (FDA) 2023 Ms. Parul Patel
Certification
First Aid trainer
Timeline
Deputy Manager in Production
Biological E. Ltd.
12.2020 - Current
Sr. Executive in Production Department
Mankind Pharma Pvt. Ltd
12.2018 - 07.2020
Sr. Executive in Production Department
Pfizer Healthcare India Pvt. Ltd.
05.2017 - 12.2018
Sr. Executive in Production Department
Mylan Laboratories Ltd, Bangalore (Oncology)
01.2016 - 04.2017
Sr. Executive in Production Department
Rusan Pharma Ltd.
07.2015 - 12.2015
Sr. Officer in Production Department
Akorn India Pvt. Ltd.
05.2012 - 04.2015
Pharmacist in Production Department
Zuventus Healthcare Limited
02.2011 - 04.2012
Asst. Officer in Production Department
Mankind Pharma Pvt Ltd.
08.2009 - 07.2010
10th - undefined
HPBSE-Dharamshala
12th (Non-Medical Science) - undefined
HPBSE-Dharamshala
B. Pharmacy - undefined
A.S.B.A.S.J.S. Memorial college of Pharmacy
MBA - undefined
Vinayaka Mission University