Janaksinh Brahmbhatt
Edmonton, Alberta
Summary
Highly motivated and committed individual with a strong background in the pharmaceutical industry. Possessing both theoretical knowledge and practical experience gained through college studies and work placements. Goal is to leverage these skills to build a successful career. Extensive experience in Formulations and Quality Management Systems (QMS), particularly in quality and production process execution, while ensuring compliance with GDP,cGMP and USFDA standards.
Overview
20
20
years of professional experience
Work History
Warehouse Associate
Amazon Fulfillment Centre
09.2023 - Current
- Department: Vendor receive & Quality Department.
Deputy Manager - Manufacturing operation & QMS -Unit I
Zydus Cadila Ltd
06.2015 - 02.2023
- Company Overview: (USFDA approved facility)
- Handling line production on each machine & day to day production.
- Planning the manufacturing schedule with manpower allocation on daily basis with respect to target production on each equipment.
- Daily communication through emails for any delay in production or any obstacles in production line.
- Prepared the daily production report at the end of shift & report to Manufacturing head.
- Tracking on completion of batches & their QC report for packaging line set up.
- Looking monthly inventory & ordered material from store as per plan.
- Daily communication to concern department like Purchasing, HR, Admin, QC, Maintenance etc
- Handling breakdown of line with maintenance team & troubleshooting mechanical problems, process problems.
- Prepared & tracking product quality report on daily basis.
- Analyze & implementation on process improvements & cycle time reduction (Kaizen Projects)
- Handling manpower & their training with respect to job profile & Safety on floor.
- Monitor the completion of task & ensure good performance of equipments-OEE
- Handling documentation work of each product & SAP entry online on floor.
- Working as team & ensure positive working environment on manufacturing floor.
- Set measurable, challenging goal & work on task for completion on time with zero defects.
- Actively work as team member in Quest team, kaizen group, Internal Audit team.
- Review of BMRs & their released through SAP system for packing line.
- Review of manufacturing documents with respect to cGMP & GDP & audit preparations.
- Handling Installation of new equipment's & validation of equipment's on shop floor with FAT.
- SOPs preparation & their training before implementation on shop floor.
- Investigate Deviation & Handling change control in facility (Track wise )
- Handling CAPA compliance & effectiveness on shop floor.
- preparation & execution of validation protocol on shop floor.
Assistant Manager- Tablet Manufacturing unit
Torrent Pharmaceutical Ltd
02.2014 - 06.2015
- Company Overview: (USFDA approved facility)
- Handling Tablet manufacturing operation & scheduling Man & Machine.
- Handling Deviations & CAPA through Track wise system.
- Handling SOPs of departments (Preparation, training & renewal at time interval)
- Handling engg & validation batches & FAT on shop floor.
- Handling documentation on shop floor which include protocol, engg batch -report, NCR etc
- Looking safety and quality measures steps in the department.
- Monitor calibration, Maintenance & validation of instruments / manufacturing Equipment.
- Monitor & report any deviation to the QA head and lead in investigation to find the root cause / CAPA.
Assistant Manager- (Solid oral Manufacturing unit)
Cadila Pharmaceutical Ltd
03.2005 - 01.2014
- Company Overview: (USFDA approved facility)
- Perform IPQC of samples Tablets as per BMR specification.
- Handling of Equipment's like, Granulation & Blending - Sifter, Mill, RMG, FBD, Auto clave & Blender (Egg shell, Conta blender), Roll compactor etc
- Compression - Cadmach, Fette (Single/Double rotary) compression machines etc
- Coating - Ganson coater, Glatt coater, Bhole autocoater & Colloidal mill.
- Online documentation like, Batch manufacturing record, equipment log book, environment data log book, cleaning logs books ,Control forms etc.
- Perform machine set up as per SOPs in batch manufacturing record.
- Handling rejection as per SOPs in plant.
- Monitor calibration, Maintenance & validation of instruments / manufacturing Equipment.
- All other tasks completion on time as suggested by production Manager in shift.
Education
MASTER OF PHARMACY - QA
GUJARAT UNIVERSITY
Gandhinagar03-2010
BACHELOR OF PHARMACY -
GUJARAT UNIVERSITY
Gandhinagar06-2004
Skills
- Decision-making
- Team leadership
- Process and procedure development
- Operations management
- Employee scheduling - Training, Qualification
- Problem-solving & Compliance
- Time management
- Multitasking and organization
- Adaptability and flexibility
- Verbal and written communication
- Scheduling and planning
- Workplace safety compliance
- Process improvement strategies
- Closing oversight
- Work Planning and Prioritization
- Documentation review-Control
- Validation protocols
- Internal audits & reports
- Continuous improvement
- Operation Monitoring-OEE
- Regulatory compliance
- Complaint investigation
- Trend analysis
- Audit reporting
- QA documentation
Other Experience
- Sound knowledge of c GMP and GDP on shop floor.
- New project facility set up executed for solid orals products. (Torrent Pharma SEZ (Gujarat-India) plant set up with USFDA audits)
- Handling of SAP system, SCADA system and LIMS , Track wise & Minitab in manufacturing operation unit.
Professional References
- Mr. Brijesh Shah, GM -Operations, Aavis pharmaceuticals, USA, +1-706-586-6338
- Mr. Krishna Barla, Ex .GM -Operations -Zydus Cadila ltd., India, +91-9974051336
- Mr. Ganapat Pote, VP-Operation, Glenmark Pharma Ltd -GOA,India, +91-7600021458
- Mr. Kirti Patel, Sr. Manager-Zydus Cadila - Ahmedabad,India, +91-97250 07540
- Mr. Vishal Shah, DGM- CQA , Zydus Cadila Ltd, Ahmedabad-India, +91-90998 59571
- Mr. Pratik Patel, GM-Manufacturing Operations,Torrent pharma Ltd, SEZ Bharuch,Gujarat- India, +91-98253 15698
Personal Information
Visa Status: Permanent residency (PR) with family in CANADA. Having US visa B1/B2 with family.
Pharma Audit Experience
- USFDA plant exposure since 2005 to 2023 (ZYDUS CADILA, TORRENT PHARMA, CADILA PHARMA - INDIA)
- USFDA, TGA (Australia), MHRA (UK), MCC (Brazil), WHO, ANVISA audit experience on shop floor in Pharmaceutical Industry.
- First prize in Quality programme (QUEST project Lead by Team McKinsey-USA) handle on shop floor, awarded by MD (Mr. Pankaj Patel sir -Zydus cadila group)
Desclaimer
I, hereby declare that the information provided above is correct and truthful up to my knowledge and belief.
Timeline
Warehouse Associate
Amazon Fulfillment Centre
09.2023 - Current
Deputy Manager - Manufacturing operation & QMS -Unit I
Zydus Cadila Ltd
06.2015 - 02.2023
Assistant Manager- Tablet Manufacturing unit
Torrent Pharmaceutical Ltd
02.2014 - 06.2015
Assistant Manager- (Solid oral Manufacturing unit)
Cadila Pharmaceutical Ltd
03.2005 - 01.2014
MASTER OF PHARMACY - QA
GUJARAT UNIVERSITY
BACHELOR OF PHARMACY -
GUJARAT UNIVERSITY
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