Charan Y N
Quality Assurance/GMP
Bengaluru
Summary
Quality - savvy with 5 years and 3 months of documented quality assurance success. Develops specific and measurable goals, improvements, and standards to continuously and consistently improve quality and reduce errors. Successfully audits and maintains product accuracy and timely delivery resulting in customer satisfaction. Initiates quality-related SOP training and enforces procedural adherence.
Overview
5
5
years of professional experience
5
5
Languages
Work History
Chief Operating Officer
Arch Group (sidezz.in)
10.2023 - Current
- Led operational oversight and project implementation for an FMCG food tech startup.
- Monitored key business risks and established risk management procedures.
- Aligned organizational objectives with company mission to increase quality and integrate work strategies.
- Refined organizational structure to consolidate, streamline, and delineate necessary functions.
- Demonstrated ability to lead and motivate in a team environment. Demonstrated ability to influence peers and across functions.
QA Executive
Syngene International LTD
07.2021 - 10.2023
- Evaluated quality problems and performed assessments to identify and resolve issues.
- Drafted technical documents such as deviation reports, testing protocol and trend analyses.
- Improved Quality processes for increased efficiency and effectiveness.
- Updated quality assurance standards, methods, and procedures to meet compliance requirements as per the regulatory standards.
- Wrote and implemented new rework procedures to standardize processes and streamline workflow.
- Expertise on Deviation management, CAPA, Change control, CAPA implementation and Self inspection.
- Coordinated and oversaw periodic audits to evaluate product quality and safety and address non-conformances.
- Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
QA Associate
Viatris (Formerly - Mylan laboratories limited)
08.2018 - 07.2021
- Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
- Spearheaded media fill runs in a sterile manufacturing facility as per the regulatory compliance standards.
- Educated employees on specific QA standards and confirmed maintenance of standards.
- Monitored product standards and quality-control programs.
- Recorded findings of inspection process, collaborating with quality team to implement corrective actions.
- Addressed non-conformance issues, pausing production to correct errors.
- Performed standard first article inspections and random sampling inspections to verify adherence to customer standards.
- Reviewed production processes and identified potential quality issues.
- Reviewed and validated quality requirements for manufacturing planning, supplier purchase orders, and engineering specifications to meet contract compliance regulations.
Education
Master of Science - Microbiology
Bangalore University
Bengaluru 04.2001 -
Bachelor of Science - Biotechnology, Biochemistry, Genetics
Sheshadripuram First Grade College. Yelahanka, Bangalore University
Bengaluru 04.2001 -
Skills
Knowledge of cGxP, ICH, EU and USFDA Guidelines
undefinedTimeline
Chief Operating Officer
Arch Group (sidezz.in)
10.2023 - Current
QA Executive
Syngene International LTD
07.2021 - 10.2023
QA Associate
Viatris (Formerly - Mylan laboratories limited)
08.2018 - 07.2021
Master of Science - Microbiology
Bangalore University
04.2001 -
Bachelor of Science - Biotechnology, Biochemistry, Genetics
Sheshadripuram First Grade College. Yelahanka, Bangalore University
04.2001 -
Personal Information
- Date of Birth: 12 September, 1994
- Nationality: Indian
- Marital Status: Single
Disclaimer
I hereby declare that all the above-mentioned details are true to the best of my knowledge.
Hobbies
- Cooking
- Reading
Declaration
I hereby declare that all the above-mentioned details are true to the best of my knowledge.
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