Chethana A
Bangalore
Overview
7
7
years of professional experience
Work History
Senior Executive Quality Assurance
Veeda Clinical Research ltd
10.2023 - Current
Executive
Bioneeds India Pvt ltd
01.2022 - 10.2023
Scientist (Compliance and Reviewer)
Anthem Biosciences Pvt. Ltd
06.2017 - 05.2021
Education
M.Sc. - Organic Chemistry
Centre for Nano and Material Sciences, Jain University, Bengaluru
01.2017
B.Sc. - Chemistry, Botany & Zoology
A.V.K. Women's College, Davangere
01.2015
Skills
- Operating System: Windows
- Microsoft Office (Word, Power point, and Excel)
- LIMS
- TIMS
- Preparation, Reviewing and updating standard operating procedures (SOPS)
- Conducting GLP training to the staff on Sops and OECD documents
- Preparation of and updating of study based inspection schedule of QAU
- Archiving of QA documents
- GLP inspections and sponsors/client visits when required
- GMP Knowledge
Languages
English
Kannada
Hindi
Telugu
Job Profile
Testing of raw material analysis, In process, Finished product analysis, Good knowledge in execution of all analytical methods related to analysis of drug substances, Working in CGMP lab with well aware of regulatory compliance, GDP and GLP environment, Preparation of SOP's, Training matrix, Job description for employee and review of training files, Responsible for training coordinator activity which includes providing training questionnaire, submitting GTR to archival to QA, Review of Raw material. Finished products, Intermediates analytical reports, Responsible to complete all planned quality and compliance training as and when required by the department/section asked by the HOD/ section head, Review of Analytical Method Validation Reports, Instrument Qualification Reports, Responsible to initiate and inform immediately to department designee /HOD if there any laboratory incidents, deviations, CCF, OOS results were observed, Responsible to conduct any job assigned by the superior, Knowledge of, Change control, CAPA and deviation management, Communication with the inter department like Quality assurance, Production, Warehouse, EHS, Maintaining copies of all approved study plans and standard operating procedures, Having access to an up-to-date copy of the master schedule, Verifying that the study plan contains the information required for compliance with the principles of good laboratory practice and this verification should be documented, Conducting study based, process based and facility-based inspections to determine if all studies are conducted in accordance with the principles of good laboratory practice and retain the records of such inspections, Determining that study plans and standard operating procedures have been made available to study personnel and are being followed, Inspecting the final reports to confirm that the methods, procedures and observations are accurately and completely described and that the reported results accurately and completely reflect the raw data of studies, Promptly reporting any inspection results in writing to management and to the study director and to the principal investigator(s) and the respective management, when applicable, Signing the study plans and study reports of all the departments on behalf of QAU, Primarily responsible for conduct of in-life phase inspections and verification/ inspection of all study related documents of bio analytical department, Preparation, Reviewing and updating standard operating procedures (SOPS), management guidelines and in-house documents, Distribution of SOP's/amendments /formats and withdrawal of previous version, Conducting GLP training to the staff on Sops and OECD documents, Conducting audits of contract testing laboratories and evaluation of vendors / suppliers, Preparation of and updating of study based inspection schedule of QAU, Receipt of documents, filing and maintenance of documents and records, Archiving of QA documents, Participating in periodic discussions with test facility management, study directors and other staff whenever required, Interacting with the representatives of monitoring authorities during GLP inspections and sponsors/client visits when required, Issue of controlled documents, Carrying out any other responsibilities as and when indicated by the HOD/Test facility Management from time to time based on the requirement
Value Proposition
Seeking for an opportunity to enhance my knowledge and experience and to gain more exposure in upcoming interdisciplinary field of science. A motivated and diligent team player utilizing excellent communication, interpersonal skills with strong analytical mind-set to learn quickly, to analyze the situation, identify requirements and provide solutions.
Personal Information
- Father's Name: B G . Ashwathnarayana
- Date of Birth: 07/22/1994
- Gender: Female
- Nationality: Indian
- Marital Status: Married
Disclaimer
I hereby declare that the above furnished information's are true to the best of my knowledge and belief.
Timeline
Senior Executive Quality Assurance
Veeda Clinical Research ltd
10.2023 - Current
Executive
Bioneeds India Pvt ltd
01.2022 - 10.2023
Scientist (Compliance and Reviewer)
Anthem Biosciences Pvt. Ltd
06.2017 - 05.2021
M.Sc. - Organic Chemistry
Centre for Nano and Material Sciences, Jain University, Bengaluru
B.Sc. - Chemistry, Botany & Zoology
A.V.K. Women's College, Davangere