Sreekanth Kutagulla
Quality - Clinical & PV
- Role
- Assistant Manager at Lotus Pharmaceutical Co., Ltd
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Sreekanth Kutagulla
A result-oriented professional with 13+ years of experience in Pharmaceutical Industry…
Experience
Assistant Manager
Jan 2023 — Present · IN
Execution of GCP, GLP, PV and Internal compliance audits; including risk evaluation, planning, conduct, reporting, follow-up, CAPA review and audit closing.Conduct Risk Evaluation and Assessment in the entire phase of Clinical Studies.Prepares CAPA Plan for responding to Audit findings and Queries.Writing and revision of GCP and PV SOPs and other GCP/GLP/PV related quality documents forming part of the GCP and PV Quality Systems.
Education
Global Pharma Regulatory Affairs Consultants-RAAJ, Thane
Advanced PG Diploma in Drug Regulatory Affairs
2011 — 2012
RIPER/JNTU-Anantapur
Bachelors
2006 — 2010
JSS University, Mysore
M.Pharm
2010 — 2012
Skills
- Drug Delivery
- Bio Research and Quality Management
- Glp
- Formulation
- Pharmaceutical Industry
- Sop
- Pharmacology
- Regulatory Affairs
- Pharmacovigilance
- Pharmacokinetics
- Regulatory Submissions
- Anda
- Ich-Gcp
- Regulatory Filings
- Regulatory Requirements
- Ind
- Generic Programming
- Ctd
- Validation
- Dmf
- Hplc
- Ectd
- Gcp
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