Samir Patel Email & Phone Number
Quality Manager @ Tri Pac, Inc.
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Samir Patel Location
- United States
Samir Patel Work
- Quality Manager @ (October 2022 - Present)
- Quality Assurance Specialist @ (May 2020 - August 2022)
- Quality Assurance Manager @ (August 2010 - September 2018)
- Quality Assurance Executive @ (September 2008 - August 2010)
- Quality Assurance @ (January 2004 - August 2008)
Samir Patel Education
- Academy of Applied Pharmaceutical Sciences
Post-Graduate Diploma in Quality Assurance and Regulatory Affairs – Food (Pharma and Cosmetics, Pharmaceutical Sciences)
2019-2019 - Indira Gandhi National Open University
Post Graduate Diploma In Management (Business Administration and Management, General)
2005-2008 - Gujarat University
Master of Science - MS (Organic Chemistry)
2001-2003 - Gujarat University
Bachelor of Science - BS (Chemistry)
1998-2001 - Gujarat University
Samir Patel Skills
- 5S
- Adverse drugs reaction (ADR)
- Advertising compliance & Promotions
- Agency Liaison
- Auditing
- CMC Regulatory Affairs
- Change Control
- Change Management
- Chemistry
- Communication
- Complaint Management
- Computer System Validation
- Continuous Improvement
- Continuous Process Improvement
- Corrective and Preventive Action (CAPA)
- Customer Relationship Management (CRM)
- DOT Compliance
- Data Analysis
- Data Integrity
- Data Quality Control
- Decision-Making
- Design Control
- Deviation
- Deviation Management
- Deviations
- Document Management
- Document Review
- Drug submission
- Electronic Common Technical Document (eCTD)
- Enterprise Resource Planning (ERP)
- Environmental Monitoring
- FDA GMP
- Global Regulatory Compliance
- Global coordination of Approval
- Good Clinical Practice (GCP)
- Good Laboratory Practice (GLP)
- Good Manufacturing Practice (GMP)
- GxP
- Hazard Analysis and Critical Control Points (HACCP)
- ISO 13485
- ISO 14971
- Incident Management
- Interact with regulatory agencies like USFDA, HC, EMA
- Internal Audit
- Internal Audits
- Internal Controls
- Investigation
- Labeling & Product Monograph
- Laboratory Information Management System (LIMS)
- Lean Manufacturing
- Lean Operations
- Lean Process Improvement
- Maintenance Management
- Manufacturing Engineering
- Manufacturing Operations
- Manufacturing Operations Management
- Medical Devices
- Microsoft Office
- Organization Skills
- Out of Specification
- Patent & intellectual Property Rights
- Post approval activities & compliance
- Problem Solving
- Process Engineering
- Product Complaints
- Product Support
- Project Management
- Quality Assurance
- Quality Auditing
- Quality Control
- Quality Management
- Quality Management System
- Regulatory Affairs
- Regulatory Compliance
- Regulatory Documentation
- Regulatory Reporting
- Regulatory Requirements
- Regulatory Strategies
- Regulatory Submissions
- Reimbursement Strategies
- Risk Assessment
- Risk Management
- Root Cause Analysis
- Six Sigma Black Belt
- Standard Operating Procedure (SOP)
- Statistical Process Control (SPC)
- Teamwork
- Test Planning
- Time Management
- TrackWise
- Troubleshooting
- U.S. Food and Drug Administration (FDA)
- U.S. Title 21 CFR Part 11 Regulation
- Validation (Drug Manufacture)
- Vendor Management
- Writing
- cGMP manufacturing
- cGMP practices
- customer complaint
- self audit & vendor audits
Samir Patel Summary
- Samir Patel, based in United States, is currently a Quality Manager at Tri Pac, Inc.. Samir Patel brings experience from previous roles at Apollo Health and Beauty Care, Dishman Carbogen Amcis Ltd, Lupin and Concord Biotech Limited. Samir Patel holds a 2019 - 2019 Post-Graduate Diploma in Quality Assurance and Regulatory Affairs – Food in Pharma and Cosmetics, Pharmaceutical Sciences @ Academy of Applied Pharmaceutical Sciences. With a robust skill set that includes 5S, Adverse drugs reaction (ADR), Advertising compliance & Promotions, Agency Liaison, Auditing and more. Samir Patel has 1 emails and 1 mobile phone numbers on RocketReach.
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