Chintan J. Patel
Killa-Pardi,GJ
Summary
Seeking challenging position in Quality Control function where I can utilize in the benefit of the organization. Having huge experience in Quality department in reputed pharmaceutical company having US-FDA, MHRA, TGA, WHO and other international FDA approvals.
Overview
1
1
Language
2
2
Certifications
21
21
years of professional experience
Work History
Manager ADL
Alkem Laboratories Limited
06.2012 - Current
- Reporting to Sr. General Manager for day-to-day laboratory activities.
- Heading team of 10 employee.
- Ensure compliance with regulatory requirements, company policies and industry standards for quality control and compliance.
- Ensure compliance with cGMP, USFDA, EUGMP, MHRA, WHO and other regulatory requirement.
- Manage OOS/OOT investigations, CAPA, Change controls, Deviations and quality risk assessments.
- Lead and manage the complete Quality control function including Analytical testing of Finish Product, Raw materials and Stability Samples timely release.
- Monitor laboratory productivity, Compliance and turnaround time (TAT).
- Lead and Mentor of the Method Validation for drug Product, Method Transfer, Method verification for API, Pharma Update evaluation, Vendor Update evaluation, Excipient Validation, Cleaning Method Validation and multimedia dissolution profile, Instrument calibration activity.
- Responsible to establish, validate, upgrade and implement the Quality Management System.
- Collaborate with cross-functional teams to resolve issues related to product quality.
- To support in providing document to Regulatory department.
- Responsible for planning day to day laboratories work and managing the troubleshooting for modern analytical instruments like LC-MS/MS (Sciex 5500+) for Nitrosamine impurities and Genotoxic impurities, HPLC (Waters, Agilent), GC-HS (Perkin Elmer), ICPMS (Perkin Elmer) for Elemental Impurities, Dissolution (Electro lab), Potentiometer (Metrohm and Mettler Toledo) Particle size analyzer 2000 and 3000 (Malvern), Ion chromatography (Metrohm and Dionax).
- To identify the needs and to provide resources, adequate facility requires for effective and efficient functioning of the department for timely analysis of samples.
- Supporting in preparing of response pertaining to Analytical deficiencies raised by Regulatory Agency via USFDA, MHRA, TGA, WHO etc. for (Drug product and drug substances).
- Responsible for analytical support at time of scale up, exhibit batches and commercial product, if any analytical Support and guidance.
- Responsible for giving training and qualification to new employee.
- Support and guidance to QMS team to find out actual root cause in laboratory OOS, OOT and Incident.
- Prerequisite for Chemical/Equipment /reagent/HPLC, GC columns/Impurities, working standards and reference standard etc management for lab liaising with staff and supplier.
- Review of Standard test procedure, Specification, Drug master file for raw materials and finished products.
- Review of Protocol and raw data for method validation / verification, Method transfer & Method equivalency and their reports.
- Responsible for Analytical Cleaning Method Validation.
- Handling Pharmacopeia Update (USP, EP, BP) Evaluation.
- Handling the Change Control and CAPA through Track wise.
- Daman (USFDA, MHRA, TGA, WHO Approved – Solid oral and Dry Powder formulation Plant)
Sr. Officer Quality control department
Sun Pharmaceutical Industries
07.2008 - 06.2012
- Analysis of Method Validation, Method transfer, Process validation and Stability sample.
- Preparation of Method Validation & Method Transfer protocol & Report.
- Handling of FDA query related to Method Validation.
- Analysis and comparison of Dissolution profile in different medium with Innovator.
- Handling of Instrument Calibration & Trouble shooting of HPLC, UPLC, Particle size & Dissolution Apparatus.
- Handling of Working Standard & Reference Standard.
- Handling of OOS and laboratory incident Sample analysis in presence of R&D Person.
- Knowledge about LIMS.
- Dadra (USFDA, MHRA, TGA, WHO Approved – Solid oral formulation Plant)
Officer Quality control department
Intas Pharmaceutical Ltd
09.2007 - 07.2008
- Analysis of Method Validation & Method transfer sample.
- Preparation of Method Validation, Method Transfer & Method Verification protocol & Report.
- Handling of Instrument Calibration & Trouble shooting of HPLC, UV & Dissolution Apparatus.
- Analysis of Raw Material, Exhibit Batch Sample, Process validation and cleaning Validation sample.
- Ahmedabad (USFDA, MHRA, WHO Approved – Solid oral formulation Plant)
Jr. Officer Quality control department
IPCA Laboratories Ltd.
04.2007 - 09.2007
- Analysis of Finish product Sample by HPLC, UV & Dissolution
- Analysis of Process validation and Method transfer sample analysis.
- Preparation of Specification and Standard test procedure as per pharmacopeia.
- Preparation of Finish Product Report.
- Athal (MHRA, WHO Geneva Approved – Solid oral formulation Plant)
Chemist in Quality control department
S. Kant Healthcare Ltd.
04.2005 - 03.2007
- Analysis of Finish product Sample by HPLC, UV & Dissolution.
- Responsible for planning day to day laboratories work with online documentation.
- Analysis of Raw material sample analysis.
- Preparation of Specification and Standard test procedure as per pharmacopeia.
- Calibration of Laboratory instrument.
- Preparation and issuance of BMR & BPR.
- Vapi (WHO Geneva Approved – Solid oral formulation Plant)
Education
Bachelor of Science - Chemistry
V. N. South Gujarat University
Surat01.2004
Higher secondary education - Science
D.C.o. High school Pardi
Valsad01.2001
Secondary education - undefined
D.C.o. High school Pardi
Valsad01.1999
Skills
Ability to motivate & create a Change
Skill Vision of Excellence and Leadership
Good interpersonal relationship with colleagues and cross functional Team
Certification
Certificate in Office Automation from INFOTECH COMPUTER EDUCATION, Killa-Pardi.
Interests
My areas of interest- Quizzing, Photography & Sports like Cricket & Chess I am fond of listening Soft Music
Timeline
Manager ADL
Alkem Laboratories Limited
06.2012 - Current
Sr. Officer Quality control department
Sun Pharmaceutical Industries
07.2008 - 06.2012
Officer Quality control department
Intas Pharmaceutical Ltd
09.2007 - 07.2008
Jr. Officer Quality control department
IPCA Laboratories Ltd.
04.2007 - 09.2007
Chemist in Quality control department
S. Kant Healthcare Ltd.
04.2005 - 03.2007
Secondary education - undefined
D.C.o. High school Pardi
Higher secondary education - Science
D.C.o. High school Pardi
Bachelor of Science - Chemistry
V. N. South Gujarat University
Declaration:
I hereby declare that the above mentioned information is correct to the best of my Knowledge, and I bear the responsibility for the above mentioned particulars.
Additional Information:
I am a responsible, hardworking and a result- oriented person with strong determination that drives me to perform better under pressure situations. A team player, with high logical and analytical abilities, I believe in growth through continuous learning and application of the knowledge.