Akshay Patil
Bengaluru
Summary
Experienced Senior Quality Executive with extensive knowledge in Extractable-Leachable, Quality Management Systems, project management. Proven track record in developing and managing analytical methods, document management systems. Regulatory activities, Quality assurance activities.
Overview
6
6
years of professional experience
Work History
Senior Quality Executive
Syngene International Limited
Bengaluru
05.2021 - Current
- Managed on-site document control team and developed efficient document management systems resulting in timely delivery of Lifetime Quality Records.
- Created master document templates and forms as needed to improve document management processes
- Ensured site-based document management activities were in compliance with approved processes and procedures
- Execution of Analytical method validation for Extractable-Leachable, Medical devices, Injectables, etc.
- Prepared of analytical method validation protocols, reports, SOPs, assessment reports according to the guidelines.
Research Associate
Lupin Bioanalytical Research
Pune
09.2017 - 04.2021
- Response to FDA queries in timely manner
- Co-ordinated with various departments like clinical, QC, BR teams
- Gained knowledge of 21 CFR, Medical devices used in Pharmaceutical industry.
- Reviewed analysis results and compilation of the same.
- To perform familiarization, validation of methods as per the regulatory requirement, to follow ALCOA+ during work.
- Reviewed incoming and outgoing documents for compliance to requirements.
Education
Master of Science - Organic chemistry
Modern College, GK
07.2017
Skills
- Medical Devices
- GxP and Regulatory requirements, Guidelines ISO 13485, ISO 9001, etc
- Extractable and Leachables
- Microsoft Office, Document management, CAPA
- Root Cause analysis
- Incident handling
- Effective Leadership
- Led and motivated a team of 04 in implementing quality control processes, resulting in a 30% increase in productivity
- Instrumental skills HPLC, GC, IR, UV, Autotitrator, etc
Websites
Accomplishments
- International Experience, Baxter Healthcare, Castlebar, Ireland, Mar 2022, Apr 2023
- Involvement in Investigations of analytical Incidents.
- Responded to regulatory queries and adopt necessary changes towards compliance.
Languages
- Marathi Native
- English Proficient
- Hindi Proficient
References
- Lupin RM Abhijit Kakad(Ass. Director), 919860136016
- Syngene RM Dr. Amarababu Anjaneya(PhD), 919901801600
References
References available upon request.
Timeline
Senior Quality Executive
Syngene International Limited
05.2021 - Current
Research Associate
Lupin Bioanalytical Research
09.2017 - 04.2021
Master of Science - Organic chemistry
Modern College, GK
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