Prasanna Kumar
Quality Assurance at Virchow Biotech Pvt Ltd
- Role
- Deputy Manager at Virchow Biotech
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Prasanna Kumar
CSV validation as per GAMP5 guidelines and QMS activities such as OOS, OOT, Laboratory…
Experience
Deputy Manager
Oct 2024 — Present · IN
Review and approval of SOP, Specification, STPs.2. Approval of Analytical reports.3. Review and approval of Analytical batch COAs.4. Investigation of non confirmation such as OOS, OOT, OOL, Deviations and laboratory incidents.5. Review and approval of Change initiation and CAPAs 5. Monitoring of compliance in various areas.6. Conducting internal audits as per the schedule and reporting the observation.7. Coordination with regulatory audits.8. Review and approval of Analytical method validation, cleaning validation protocols and reports.
Education
Krishna University, Machhlipattanam
masters , Analytical Chemistry
2011 — 2013
Omasy Research
Diploma in Regulatory affairs and Pharmacovigilance, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs
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