Prem Latha
M.Sc. Biotechnology • QMS Executive • Clinical Research Professional
About
Detail-oriented QMS Executive with 2+ years of hands-on experience in pharmaceutical quality management, deviation handling, change control, and regulatory documentation. Academically trained in Biotechnology with internship exposure to Clinical Research, Pharmacovigilance, Clinical Data Management, and Medical Coding. Committed to ensuring GMP compliance and driving continuous quality improvement in pharma and clinical environments.
Experience
QMS Executive - Biocon Biologics - Bangalore
(2024-02)
- Managed end-to-end deviation management: initiation, root cause investigation, CAPA, and closure
- Raised and tracked change controls and change actions in compliance with GMP standards
- Authored, revised, and reviewed Standard Operating Procedures (SOPs) and Batch Production Records (BPRs)
- Supported JUSE certification activities and contributed to Deming Award quality improvement initiatives
- Led 5S workplace organization initiatives across production and QC areas
Quality Control Analyst - Allianz Biosciences
- Performed QC testing and documentation in compliance with standard pharmaceutical protocols
Quality Control Analyst - VJ Biotech
- Conducted analytical testing, maintained QC records, and ensured adherence to SOPs
Internship – Clinical Research
Internship – Clinical Data Management
Internship – Pharmacovigilance
Internship – Medical Coding
Education
M.Sc. - Biotechnology - KSG College (Bharathiar University) (2022 - 2024)
B.Sc. - Biotechnology - KSG College (Bharathiar University) (2019 - 2022)
