Professional Summary
Pharmaceutical professional with 4.5+ years of experience in Quality Management Systems (QMS), GMP compliance (EU & FDA), and remediation activities.
Expertise in SOPs, CAPA, deviations, change control, audit readiness, and regulatory compliance. Strong experience in risk assessment, validation support, and cross-functional collaboration.
Work Experience
Executive – QMS & Documentation Compliance
Extrovis Pvt. Ltd (2024–Present)
- Managed 100+ QMS documents (SOPs, STPs, specifications)
- Handled CAPA, deviations, change control tracking
- Performed risk assessments (ICH Q9)
- Supported audits & regulatory submissions
- Trained teams on GMP compliance
Research Associate – Analytical Development
Mylan R&D (Viatris) (2021–2024)
- Worked on OOS, OOT, deviation investigations
- Performed method development & validation
- Handled vendor notifications & gap assessments
- Supported audit readiness & compliance
Trainee Analytical Scientist
Medcent Pharma (2021)
- Worked on HPLC, UV, IR, KF instruments
- Supported SOPs, CoA, and documentation
- Performed IQ, OQ, PQ activities
Skills
QMS & Regulatory: GMP, CAPA, Deviations, Change Control, Audit Readiness
Analytical: HPLC, UPLC, UV, IR, KF, Dissolution
Documentation: SOPs, STPs, Specifications, CoA
Tools: LIMS, TrackWise, Empower, SAP
Projects & Publications
- Peptide Drug Delivery Review (Springer Publication)
- RP-HPLC Method Development Research Paper
- GAP Assessments (API, Excipients, Finished Products)
- Extractables & Leachables Study
Education
MSc Pharmaceutical Business & Technology – Griffith College (Ireland)
B.Pharmacy – Andhra University (India)