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Dirgeshkumar Patel is listed as CEO, Pramukh Pharma Bridging and Director at Antalya Analytical Solutions LLP at Antalya Analytical Solutions, based in Ahmedabad, Gujarat, India. AeroLeads shows a matched LinkedIn profile for Dirgeshkumar Patel.
Dirgeshkumar Patel previously worked as Director at Antalya Analytical Solutions and Chief Executive Officer at Pramukh Pharma Bridging. Dirgeshkumar Patel holds Certification, Lead Auditor Iso 9001:2015 from The Knowledge Academy.
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More than 22 years of rich & qualitative experience in Pharmaceutical Industry,Having experience in the dosage form (Sterile and non-sterile Manufacturing) like Oral solids, Injectable, Semi-Solid, Ophthalmic solutions, NDDS formulations and MDI,Experience in dealing with third party Quality like CMO CRO, CDL and CTL,Expertise in Quality investigations such as OOS, OOT, Deviation & Incidences with compliance and trending, Ensure Compliance of Third-Party operation and Pharmaceuticals Audits (API Vendor, CMO, CRO and Contract Testing Lab), Participate as a team member in developing CMO and CTL and getting ready for PAI,New Product Launches (Validation and commercial batches)Proven excellence in Data Integrity by challenging & implementing Validation and Quality Assurance Strategies through risk-based evaluation and decision making,Expertise with regulatory audits such as USFDA, MHRA, TGA, WHO, Canada, ANVISA to name a few. Established key process indicators (KPI’s) and implemented preventive & corrective actions to eliminate the root causes of poor quality and delivery, Contributed to the improvement of life quality & advancement of mankind through innovative solutions & formulations with analytical method development and quality evaluation of drugs & its products,Expertise in managing quality documentations,Team-based management style coupled with the zeal to motivate subordinates with exceptional leadership skills in heading global teams.
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Ahmedabad, Gujarat, India
Antalya Analytical Solutions is coming soon with an advanced and independent laboratory in Ahmedabad. With having highest Quality Standard, we will provide exhaustive range of testing with high accuracy and precision. We strive to set new industry benchmarks to offer analytical services in pharmaceutical sector. Having dedicated and experienced scientific.
Ahmedabad, Gujarat, India
-Bridging activities for Product development specially in the field of Niche formulation, Contract Manufacturing Organization managements including quality oversite and Contract Testing Laboratory managements including quality oversite.- Providing scientific consultancy services for Innovative Generic Drug Development, Process Simplification, Productivity.
Ahmedabad, Gujarat, India
Quality Compliance Gap analysis, Risk Assessment & Remedial activities Auditing Quality Improvement Program initiatives Strategic compliance training & Inspection readiness Quality Management System Enhancement. Providing the direction to the various type of investigations Provide service to Analytical methods development and AMV. Expert in creating.
Ahmedabad, Gujarat, India
Main leader/contact for Launch New Product Development projects in India while being responsible for all their Quality Assurance aspects,Ensures that relevant GMP training is provided, recorded and updated for all India’s employees,Supports other quality systems such as change control, investigations, etc.Acts as the main contact for all Clarifax from.
Mumbai Area, India(Kenpack Pharma Pvt. Ltd.)
Responsible for Global QA activity as mentioned below for the India facility as well as US facility (Axar Pharma)Creating systems in compliance with the principles of data integrity and equipment compliance with 21 CFR Part 11.Performing audits for API & CMO, CRO and CTL facilities as per cGMP Compliance, Audit Compliance Review, CAPA response & Tracking.
Mumbai Area, India(Kenpack Pharma Pvt. Ltd.)
Ahmedabad Area, India
Spearheading two section of Quality Assurance, Analytical QA and QMSExperience to deal with various regulatory audits like-US FDA, ANVISA, Europe, all were cleared and USFDA with Zero 483.Provide direction to conduct the investigation on laboratory incidents, deviations, out of trend (OOT) and out of specification (OOS) results and ensure timely closer..
Ahmedabad Area, India
Spearheading two group,which is Analytical Method Development and Central Documentation CellAnalytical Method Development: Heading the Analytical Method development team for all the product and Markets.Headed Central Documentation: Preparation, Review and Archival & Control of Specifications/Test procedures/General test procedure of the company for all the.
Paonta Sahib
Spearheading Commercial Stability(QC) having team of 23 of commercial stability department. ( 1 for doc cell, 1 for stability sample management, 3 reviewer and 18 analyst)Responsible for overall stability operation of commercial batches from Sample management (Charging and withdrawal, reconciliation of samples), Planning of Analysis, Data Reporting.
Gurgaon, India
Extensive proven experience in analytical method development and validation in line with the ICH guidelines and Analytical Method Transfer to the PlantProficient in quality based evaluation of drug and drug product during development/optimization and stabilitySpecialize in analysis (NDDS) of Pre-oral Extended Release systems like matrix system, osmotic.
Baroda
Marketing of pharmaceutical products.
Certified Lead Auditor ISO 9001:2015
Quick answers generated from the profile data available on this page.
Dirgeshkumar Patel works for Antalya Analytical Solutions.
Dirgeshkumar Patel is listed as CEO, Pramukh Pharma Bridging and Director at Antalya Analytical Solutions LLP at Antalya Analytical Solutions.
Dirgeshkumar Patel is based in Ahmedabad, Gujarat, India while working with Antalya Analytical Solutions.
Dirgeshkumar Patel has worked for Antalya Analytical Solutions, Pramukh Pharma Bridging, Self-Employed, Jamp Pharma Group, and Famy Care Ltd., Mumbai.
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Dirgeshkumar Patel holds Certification, Lead Auditor Iso 9001:2015 from The Knowledge Academy.
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