CHETHAN T.P
Koratagere
Summary
Experienced administrative professional knowledgeable about registrations, audits, inspections and other industry regulatory proceedings. Special skill in managing complex documentation, reports and data for regulatory reporting and compliance. Exceptional public relations skills. Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with exceptional data analysis, report writing and record keeping abilities.
Overview
5
5
years of professional experience
Work History
RA Associate
Parexel International Pvt Ltd
2022.09 - Current
- Manage the Regulatory information management systems (RIMS) activity
- Well skilled in handling of registration tool like LIQUIENT
- Handling of Data Quality Initiative (DQI) and Clinical Trials Application (CTA) updating activities
- Regulatory Publishing including Bookmarking and Hyperlinking of PDF documents, word formatting and Publishing of submission ready document using Publishing tool for submission.
- Responsible for regulatory operational activities including organizing, tracking, and sending submissions to publishing team for US and other international markets.
- Prioritized tasks to meet tight deadlines, pitching in to assist others with project duties.
- Greeted customers and offered assistance for increased customer satisfaction.
- Worked varied hours to meet seasonal and business needs.
- Managed customer relations through communication and helpful interactions.
Executive - Quality Assurance
Microlabs Labs Pvt Ltd
2019.05 - 2022.08
- Handling of QA release of Finished products
- Issuing of Product labels and QA Release labels
- Handling of Marketing Samples
- Handling of Customer Complaints and Returned goods
- Handling of Training programs as per the Nichelon 5 CMS training management software
- Preparation and Review of Validation protocols and reports
- Preparation and Review of Annual product quality review
- Review of executed BMR's, Equipment cleaning records
- Review of Intermediates, Finished and Stability Analytical data
- Knowledge of document distribution and data controlling of All Departments
- Supporting to the Dept., colleagues in Audit facing and Audit compliance.
Education
Master of Pharmacy - Quality Assurance
JSS College Of Pharmacy
Mysuru, KA04.2019
B.Pharm -
Siddaganga College Of Pharmacy
Tumakuru, KA05.2017
PUC -
Ravindra Bharathi PU College
03.2013
SSLC -
Ravindra Bharathi Vidya Mandira
03.2011
Skills
- Adaptability
- Positive and friendly
- Knowledge of quality systems
- Willingness to learn
- Microsoft applications skills
- Leadership & Teamwork
Languages
English
Kannada
Hindi
Telugu
Hobbies and Interests
- Reading Novels
- Watching Movies
- Playing video games
- Photo editing and video editing
Disclaimer
I hereby declare that the above furnished details are true and correct to the best of my knowledge
Timeline
RA Associate
Parexel International Pvt Ltd
2022.09 - Current
Executive - Quality Assurance
Microlabs Labs Pvt Ltd
2019.05 - 2022.08
Master of Pharmacy - Quality Assurance
JSS College Of Pharmacy
B.Pharm -
Siddaganga College Of Pharmacy
PUC -
Ravindra Bharathi PU College
SSLC -
Ravindra Bharathi Vidya Mandira
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