Summary
Overview
Work History
Education
Skills
Accomplishments
Affiliations
Software
Certification
Interests
Work Availability
Quote
Timeline
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Kamlesh Patel

Kamlesh Patel

General Manager - Quality
Elite One13, Vandemataram Road, Gota, Ahmedabad, Gujarat

Summary

OVERVIEW: Analytical Research & Development (Core strength) and Quality (QC & QA) background, I would like to explore skills with a medium of creativity and efficiency at top management level. With motivation and positive approach, I take up challenges as perfect opportunities. I can effectively contribute skills and to work in competitive environment and experience. I like to work with a dynamic organization in a transparent work environment, providing an opportunity for exercising scholastic learning skills on the road to fast growth.

PROFESSIONAL STRENGTH: More than 21 years’ experience in Analytical Development, QC and QA skills being the major assets. Leadership quality, hardworking, willingness to learn new thing & process fast learning ability. Expertise in introducing and implementing new ideas and changes. Planning and organizing day-to-day research activities and resolving procedural problems as appropriate to the timely completion of research objectives. Highly motivated and result oriented professional with strong analytical and team building skills. Exposure to regulatory audits like US FDA, MCC South Africa, MHRA UK, TGA Australia, WHO-Geneva, ANVISA Brazil, and ROW market for ADL related activity. Deft in Analytical Method Development, Validation for regulatory markets, Analytical Method Transfer, Process Validation, Quality Assurance and Information Technology. Hands on experience and knowledge of chromatographic techniques. Quick learner, willing to maintain current up-to-date job knowledge & skills. Excellent computer knowledge of Internet and MS office. Sound technical knowledge and very good trouble shooter of analytical methods and QC activities. Customer-oriented General Manager with [Number] years of experience focused on increasing revenues and expanding margin. Adaptive and deadline-oriented consistently executes and completes multiple projects in high-stress environments. Meticulous leader and strategic planner with comprehensive managerial acumen, offering vision and motivational acumen.

Overview

21
21
years of professional experience
4
4
years of post-secondary education
2
2
Certificates
1
1
Language

Work History

General Manager - Quality

Nivagen Pharma (India) Pvt. Ltd (A Division of Nivagen Pharmaceuticals Inc. CA, USA)
Ahmedabad
12.2019 - Current
  • Responsible for all GMP, GLP, operations follow at CMO’s
  • Perform audits of CMO, External laboratories, API manufacturer and Supplier Audits
  • Perform vendor qualification for API, Excipients and Packing materials
  • TTD documents of Finished product transfer to CMO
  • Ensure all method transfer are accomplished to CMO in timely fashion
  • Responsible for Quality documents review and implementation at manufacturing site as per regulatory compliance
  • Identify external laboratory as per requirement of tests and co-ordination between CMO and External laboratories
  • Handling of Quality deviations, Incidents, OOT and OOS investigation at CMO and External Laboratories
  • Ensure compliance and integrity of product quality respect to analytical activities at CMO and External laboratories
  • Handling and providing support for trouble shooting and technical support to Quality department and R&D team for analytical methods and activities
  • Review of TTD documents as Specifications, STPs, Quality documents and development study documents
  • Review of CMO analytical documents as per regulatory requirement
  • Prepare SOP, Specification and Test method as and when required to provide at CMO
  • Responsible for approval/rejection of material/ finished product/QMS documents
  • Review of Regulatory submission documents and ensure compliance with all regulatory requirements pertaining to product approval
  • Provide periodic update on regulatory requirement changes, which affect individual product specification or quality systems
  • Support RA team for ANDA & NDA filling and deficiency response
  • Responsible for on job training for new implementation and SOP training
  • Review of Quality documents and stability reports
  • Performs additional duties and responsibilities as assigned Management
  • Actively participates with CMO to assist successful USFDA audit.
  • Maximized efficiency by coaching and mentoring personnel on management principles, industry practices, company procedures, and technology systems.

Deputy General Manager - ADL

DORIZOE LIFESCIENCES LTD
Ahmedabad
06.2015 - 11.2019
  • As a CRO business, Provide complete TTD for Analytical activities (Method development, Method validation, Method Transfer, FP specification and STP's, etc) of Parenteral drug product to the Global clients.
  • Reviewed performance results to target and take corrective measures with authorization and escalation.
  • Informed VP of unusual matters of significance and launched corrective action plan.
  • Maintained qualified staff and communicated areas of accountability and expected performance.
  • Employed best practices and management controls to provide superior service to external customers.
  • Supported staff with developing professional skills and abilities, uplifting team performance.
  • Conducted routine inspections to check quality and compliance with established specifications.
  • Trained new team members by relaying information on company procedures and safety requirements.

Sr. Manager - Analytical Development Laboratory

ACME FORMULATION PVT. LTD
Nalagarh
04.2010 - 05.2015
  • Heading Analytical Development Team for product development of various manufacturing companies.
  • Prepare drug product dossier for new product approval for domestic Pharmaceutical industries and ROW markets.
  • WHO- Geneva essential drug product approval for Hormonal products.
  • Provide technical support to the Quality control Laboratory and Production Team for drug product.

Manager - Analytical Development Laboratory

J.B CHEMICALS & PHARMACEUTICALS LTD
Ankleshwar
12.2009 - 04.2010

Group Leader - Analytical Development Laboratory

PHARMAFFILIATES ANALYTICS & SYTHETICS (P) LTD
Panchkula
01.2008 - 11.2009

Sr.Executive-ASD (Analytical Service Department)

STRIDES ARCOLAB LIMITED
Bangaluru
02.2007 - 01.2008

Officer - R&D

SUN PHARMA ADVANCE RESEARCH CENTER
Vadodara
10.2005 - 01.2007

Officer - F&D

CLARIS LIFESCIENCES LIMITED
Ahmedabad
06.2003 - 09.2005

Chemist- QC

DISHMAN PHARMACEUTICALS & CHEMICALS LIMITED
Ahmedabad
05.2002 - 05.2003

Education

Master of Science - Chemistry

North Gujarat University
Patan, Gujarat, INDIA
03.1999 - 06.2001

Bachelor of Science - Chemistry

Gujarat University
Ahmedabad, Gujarat, INDIA
05.1996 - 05.1998

Skills

    Effective leader

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Accomplishments

  • Achieved complex compound analytical methods by completing analytical method development with accuracy and efficiency.
  • Sound knowledge used for developing various analytical methods on different HPLC's detectors (CAD, GPC, ELSD, UV, RI & PDA)

Affiliations

Participated various management skill development training at Indian Institute of Management (IIM), Indore and other Reputed management
Institution of India.

Software

Microsoft Office and Internet exploring

Certification

Participated at IIM- Indore for "Management Development Programme on Building and Leading Teams'

Interests

Exploring new analytical technical skill and updates

Motivating and Team building

Eagerness to learn new things and adaptable strategies

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote

Judge a man by his questions rather than his answers.
Voltaire

Timeline

General Manager - Quality

Nivagen Pharma (India) Pvt. Ltd (A Division of Nivagen Pharmaceuticals Inc. CA, USA)
12.2019 - Current

Participated at IIM- Indore for "Management Development Programme on Building and Leading Teams'

03-2018

Participated at MDI, Gurgaon for "Effective Communication for Managers and Leaders"

02-2017

Deputy General Manager - ADL

DORIZOE LIFESCIENCES LTD
06.2015 - 11.2019

Sr. Manager - Analytical Development Laboratory

ACME FORMULATION PVT. LTD
04.2010 - 05.2015

Manager - Analytical Development Laboratory

J.B CHEMICALS & PHARMACEUTICALS LTD
12.2009 - 04.2010

Group Leader - Analytical Development Laboratory

PHARMAFFILIATES ANALYTICS & SYTHETICS (P) LTD
01.2008 - 11.2009

Sr.Executive-ASD (Analytical Service Department)

STRIDES ARCOLAB LIMITED
02.2007 - 01.2008

Officer - R&D

SUN PHARMA ADVANCE RESEARCH CENTER
10.2005 - 01.2007

Officer - F&D

CLARIS LIFESCIENCES LIMITED
06.2003 - 09.2005

Chemist- QC

DISHMAN PHARMACEUTICALS & CHEMICALS LIMITED
05.2002 - 05.2003

Master of Science - Chemistry

North Gujarat University
03.1999 - 06.2001

Bachelor of Science - Chemistry

Gujarat University
05.1996 - 05.1998
Kamlesh PatelGeneral Manager - Quality