Srilekha Acharya
Bengaluru
Summary
Results-driven professional with extensive experience at Biocon Limited, specializing in computer system validation and regulatory compliance. Proven ability to optimize IT workflows and enhance quality management systems. Skilled in statistical analysis and adept at multitasking, ensuring adherence to GAMP and 21 CFR part 11 standards while facilitating successful audits.
Overview
12
12
years of professional experience
Work History
Assistant Manager
Biocon Limited
Bengaluru
05.2021 - Current
- Oversaw Computer System Validation for DMS, Trackwise, DCS, and SCADA platforms.
- Implemented software upgrades to comply with GAMP requirements and 21 CFR part 11 regulations.
- Streamlined regulatory compliance by optimizing IT workflows and user management policies.
- Participated in quality management activities, effectively addressing deviations through CAPA implementation.
- Facilitated internal audits and coordinated inspections by EMA, COFEPRIS, US FDA, and Health Canada.
- Authored and reviewed validation protocols for Process and Cleaning validations, along with qualification documentation.
- Conducted data management practices, including backup/restoration procedures and audit trail reviews.
- Engaged in software gap assessments to ensure alignment with current regulatory standards.
Senior Executive
Biocon Biologics Limited
Bengaluru
07.2016 - 11.2019
- Oversaw handling of QMS documents such as Change Control, Market Complaints, and CAPA.
- Conducted verification of CAPA completion by reviewing relevant documentation and ensuring closure.
- Maintained comprehensive archival of Quality Management System records for future reference.
- Coordinated training programs aimed at improving technical skills for cGMP compliance.
- Periodically reviewed department training records to confirm compliance with training schedules.
- Facilitated induction and on-the-job training for all new employees before routine task performance.
Bioprocess Engineer
Navva Biologicals
Hubli
10.2013 - 04.2014
- Performed microbial induction studies, implemented PCR techniques, executed agarose and SDS gel runs, while ensuring comprehensive documentation
Education
Master of Technology - Industrial Biotechnology
Manipal Institute of Technology
Manipal, Karnataka05.2016
Bachelor of Technology - Biotechnology
B.V.B College of Engineering And Technology
Hubli, Karnataka05.2013
Skills
- Computer system validation
- Quality management
- Regulatory compliance
- Process optimization
- Statistical analysis
- Design of experiments
- Minitab proficiency
- Software upgrades
- Multitasking and organization
Languages
English
First Language
German
Upper Intermediate (B2)
B2
Timeline
Assistant Manager
Biocon Limited
05.2021 - Current
Senior Executive
Biocon Biologics Limited
07.2016 - 11.2019
Bioprocess Engineer
Navva Biologicals
10.2013 - 04.2014
Master of Technology - Industrial Biotechnology
Manipal Institute of Technology
Bachelor of Technology - Biotechnology
B.V.B College of Engineering And Technology
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