Consultant – Pharma Compliance Training And Development
Auriga Consulting And Research Llp
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Jitendra Chavan Email & Phone Number
Consultant – Pharma Compliance Training and development
at
Auriga Consulting and Research LLP
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Current company
Auriga Consulting and Research LLP
Role
Consultant – Pharma Compliance Training and development
Location
Panvel, Maharashtra, India
Who is Jitendra Chavan? Overview
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Quick answer
Jitendra Chavan is listed as Consultant – Pharma Compliance Training and development at Auriga Consulting and Research LLP, based in Panvel, Maharashtra, India. AeroLeads shows a matched LinkedIn profile for Jitendra Chavan.
Jitendra Chavan previously worked as Consultant – Pharma Compliance Training & development at Auriga Consulting And Research Llp and Manager at Saitech Pharmaceuticals. Jitendra Chavan holds Master'S Degree, Chemisrty, Ii from Mumbai University Mumbai.
Profile bio
About Jitendra Chavan
Jitendra Chavan is a Consultant – Pharma Compliance Training and development at Auriga Consulting and Research LLP. They possess expertise in bioequivalence, anda, regulatory affairs, clinical research, glp and 8 more skills. They is proficient in Marathi, Hindi and English.
Listed skills include Bioequivalence, Anda, Regulatory Affairs, Clinical Research, and 9 others.
Current workplace
Jitendra Chavan's current company
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Auriga Consulting And Research Llp
10 roles
Jitendra Chavan work experience
A career timeline built from the work history available for this profile.
Consultant – Pharma Compliance Training & Development
Current
Auriga Consulting And Research Llp
Clinical: Clinical studies Phase I-IV, Bioequivalence, Data Management, Project Management, Monitoring, Archive/Document Management etc. Regulatory Affairs: e CTD, Regulatory dossier and SOP audits, Drug regulatory environment, communications with regulatory authorities and CAPA submissions. IT Validation: validation of computerised systems for.
Mar 2020 - Present
Manager
Saitech Pharmaceuticals
- Handling the Analytical and Quality assurance department consist of 8 to 10 staff.
- Day to day activity planning in Analytical department to support synthetic research department.
- Carry out Method development and validation in API and Intermediate.
- Preparations of IQ, OQ, PQ documents for analytical instruments.( HPLC, GC, IR,UV etc)
- SOP preparation for Analytical department.
- Preparation Analytical development report of ARD. Protocol preparation for method transfer to plant QC.
Jan 2015 - Mar 2020
Manager
- Supporting the selection and evaluation of new proposed CROs for BA/BE studies on factors such as compliance to the regulatory requirements, facility, resources and infrastructure of CROs.
- Completing the outsourced BA/BE projects on time at CROs as per specified timelines and with compliance.
- Filing of BA/BE study reports received from various CROs and ensuring proper documentation.
- Ensuring adherence to set timelines, plans, GLP norms and regulatory requirements (e.g. ICH, EDQM, US FDA) at current CROs by analyzing and monitoring bio-analytical activities.
- Imparting technical guidance to bio-analytical activities for various projects of BA/BE and on various aspects for timely availability of BA/BE report.
- Analyzing and evaluating study analytical method for proposed BA/BE projects.
Sep 2008 - Jul 2014
Manager
Mayfair Clinical And Research
- Assessing and executing novel automation, separation and detection techniques for quantitative bio-analysis and participate in Writing protocols, SOP preparation, reviewing data, etc.
- Monitoring the bio analytical department.
- Developing and validating LCMS-MS methodology for the quantitation of drugs/metabolites in biological fluids in humans Protocol reviewing.
- Monitoring clinical phase BE studies and statistical analysis
Jan 2007 - Jan 2008
Executive
Accutest Research Private Limited
- Assessing and executing novel automation, separation and detection techniques for quantitative bio-analysis and participate in Writing protocols, SOP preparation, reviewing data, etc.
- Monitoring the bio analytical department.
- Developing and validating LCMS-MS methodology for the quantitation of drugs/metabolites in biological fluids in humans Protocol reviewing.
- Monitoring clinical phase BE studies and statistical analysis
Jan 2004 - Jan 2006
Senior Analytical Chemist
Ajanta Pharma Limited
Analysis of Finished product Handling HPLC,GC,Dissolutuion,UV Instrument Wet analysis
Jan 2002 - Jan 2004
Qc Chemist
Cipla Limited
Routine analysis of Finished product Analysis of Stability study sample and Raw material analysis Handling HPLC,GC,Dissolutuion,UV Instrument Wet analysis
Jan 2000 - Jan 2002
Quality Control Chemist
Aromatic And India Chemical Private Limited
Routine analysis of Chemical and packaging material analysis.Handling Analytical instrument UV spectrophotometer,IR spectrophotometer, Atomic absorption spectrophotometer,Polarogarph,Autotirator
Jan 1997 - Jan 2000
Trainee Analytical Chemist
Emerck India Limited
Analysis of Finished product
Jan 1996 - Jan 1997
3 education records
Jitendra Chavan education
Master'S Degree, Chemisrty, Ii
Bachelor, Chemistry, First Class
Mumbai University
Diploma Of Pharmacy, Pharmacy, First Class
Mumbai University
FAQ
Frequently asked questions about Jitendra Chavan
Quick answers generated from the profile data available on this page.
What company does Jitendra Chavan work for?
Jitendra Chavan works for Auriga Consulting and Research LLP.
What is Jitendra Chavan's role at Auriga Consulting and Research LLP?
Jitendra Chavan is listed as Consultant – Pharma Compliance Training and development at Auriga Consulting and Research LLP.
Where is Jitendra Chavan based?
Jitendra Chavan is based in Panvel, Maharashtra, India while working with Auriga Consulting and Research LLP.
What companies has Jitendra Chavan worked for?
Jitendra Chavan has worked for Auriga Consulting And Research Llp, Saitech Pharmaceuticals, Inventia Healthcare Private Limited, Mayfair Clinical And Research, and Accutest Research Private Limited.
How can I contact Jitendra Chavan?
You can use AeroLeads to view verified contact signals for Jitendra Chavan at Auriga Consulting and Research LLP, including work email, phone, and LinkedIn data when available.
What schools did Jitendra Chavan attend?
Jitendra Chavan holds Master'S Degree, Chemisrty, Ii from Mumbai University Mumbai.
What skills is Jitendra Chavan known for?
Jitendra Chavan is listed with skills including Bioequivalence, Anda, Regulatory Affairs, Clinical Research, Glp, Lc Ms, Hplc, and Bioanalysis.
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