HEMAN DAHAL
Indore
Summary
Highly experienced pharmaceutical manufacturing professional with over 18 years of experience specializing in inhaler products, nasal formulations, and oral solid dosages. Proven expertise in managing production and packing operations under stringent cGMP and regulatory compliance environments. Demonstrated success in leading cross-functional teams, handling regulatory audits (USFDA, MHRA, ANVISA, etc.), and driving process optimization and quality improvement initiatives.
Overview
19
19
years of professional experience
Work History
Manager – Oral Contraceptive Packing & Documentation
Lupin Ltd
Indore, Madhya Pradesh
08.2023 - Current
- Lead all packing-related processes and documentation for Oral Contraceptive formulations.
- Ensure adherence to cGMP, GxP, and EHS standards across the shop floor.
- Promote a quality-first culture and ensure continuous learning through training and capability building.
- Proper planning and execution of batch as per received volumes.
- Drive cost-effectiveness, maintain staffing levels and oversee compliance with SOPs.
- Implement process improvements, manage QMS activities (Change Control, Deviation, CAPA), and ensure safety compliance.
- Lead different initiatives for product COGM reduction, process simplification/ automatization, batch size optimization.
Manager – MDI & DPI Manufacturing & Packing
Lupin Ltd
Indore, Madhya Pradesh
07.2021 - 07.2023
- Assisted in managing equipment and supporting area qualification for greenfield projects.
- Helped oversee manufacturing and packing processes of MDI and DPI formulations to maintain regulatory compliance.
- Coordinated batch planning and execution in accordance with monthly C vs A plans.
- Supported documentation control and manpower management for audit preparation during inspections.
- Ensured compliance with CGMP, GXP, and EHS standards across shop floor operations.
- Contributed to projects under WCM and 5S initiatives to improve shop floor efficiency.
- Monitored staff performance and developed improvement plans.
Deputy Manager – Aerosol Packaging
Cipla Ltd
Sikkim
02.2019 - 06.2021
- Handled aerosol packaging, batch planning, and master batch record reviews.
- Executed technology transfer activities and ensured QMS documentation within timelines.
- Conducted root cause analysis for deviations, OOS/OOT, and ensured CAPA effectiveness.
- Led departmental audits, SAP transactions, and personnel training programs.
Assistant Manager – Aerosol Manufacturing
Cipla Ltd
Indore, Madhya Pradesh
12.2014 - 02.2021
- Supervise the Manufacturing and packing of batches.
- Prepared and reviewed master manufacturing records and ensured audit compliance.
- Managed batch confirmation through SAP.
- Coordinated and executed the technology transfer activities of products from other sites.
- Planning and tracking of batches as per monthly plan.
- Conducted employee training on cGMP, data integrity, and process safety.
- Generated cost reduction and quality improvement initiatives.
Junior Officer – MDI Manufacturing & Packing
Glenmark Pharmaceuticals Ltd
Baddi
04.2010 - 11.2014
- Prepared equipment qualification documents (URS, OQ) and SOPs.
- Planned and executed monthly production schedules ensuring audit readiness.
- Trained juniors on machine operation, cleaning, and troubleshooting.
- Supported DGFT compliance via Track and Trace implementation.
Site Incharge – Calibration
Perfect Utilities
09.2009 - 03.2010
- Prepared calibration plans and reports for various pharmaceutical clients.
- Coordinated calibration activities for Golden Cross Pharma Ltd, Sikkim.
Management Staff – MDI Packing
Cipla Ltd
Sikkim
09.2007 - 09.2009
- Handled batch packing, online documentation, and in-process quality checks.
- Troubleshot packing machinery and supported continuous improvement.
Education
B.Sc - IT
Sikkim Manipal University
+2 -
CBSE Board
GuwahatiSkills
- Track and trace systems(Reetrack)
- Filling machines
- Blister packing machinery
- Manufacturing vessels
- Checkweighing systems
- Printing technologies
- Cartonator (CAM,Marchesini, IMA-PG
- SAP system
- Electronic document management
- Document management systems
- Trackwise software
- Process optimization
- Quality management
- Compliance oversight
- Equipment qualification
- Documentation control
- Continuous improvement
- Risk assessment
- Batch planning
- Team leadership
- Project management
- Employee training
- Performance monitoring
- Cost reduction
- Leadership skills
- DGFT systems
- Regulatory compliance
- Statistical analysis (Minitab)
- Veeva Vault
Languages
English
Hindi
Nepali
Personal Information
Father's Name: Mr. I. L. Dahal
Custom Section
- Inhalation: MDI, Nasal Spray, and DPI (Manufacturing, Packing & Documentation)
- Oral Solid Dosage: Oral Contraceptive Products (Packing & Documentation)
- Glenmark Pharmaceuticals: GCC, TGA, ANVISA, WHO, TANZANIA, UGANDA, CDSCO
- Cipla Ltd: CDSCO, MCC, MHRA, USFDA
- Lupin Ltd: MHRA, USFDA, MOH (Russia), Germany, TGA
Disclaimer
I hereby declare that the information provided above is true to the best of my knowledge and belief.
Timeline
Manager – Oral Contraceptive Packing & Documentation
Lupin Ltd
08.2023 - Current
Manager – MDI & DPI Manufacturing & Packing
Lupin Ltd
07.2021 - 07.2023
Deputy Manager – Aerosol Packaging
Cipla Ltd
02.2019 - 06.2021
Assistant Manager – Aerosol Manufacturing
Cipla Ltd
12.2014 - 02.2021
Junior Officer – MDI Manufacturing & Packing
Glenmark Pharmaceuticals Ltd
04.2010 - 11.2014
Site Incharge – Calibration
Perfect Utilities
09.2009 - 03.2010
Management Staff – MDI Packing
Cipla Ltd
09.2007 - 09.2009
B.Sc - IT
Sikkim Manipal University
+2 -
CBSE Board