Venkat
‘Senior Technical Lead-PMS’ | Quality Complaints | Medical Devices | Offshore Project Lead |
- Role
- Sr Quality Complaints Handling Specialist at Cyient
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Venkat
I hold an advanced Master\'s Degre-PharmD. I\'m HCP and experienced in QARA, MV, PV. Skills: Patient Safety, Drug/Device Safety, Quality Complaints, QARA, Team Management. Tools/Safety Database: GCHS (Salesforce), SmartSolve(IQVIA), ARGUS (Oracle), ArisG, Complaint Wizard, SAP, CareLink, JIRA, EDC, Power Bi, Spotfire. Regulations: ISO 13485-QMS, 21 CFR Part 820 & 60, EU-2017/745, ISO 14971-RM License/Certifications-Good Clinical Practice (GCP)-Product Lifecycle Management (PLM)-
Experience
Sr Quality Complaints Handling Specialist
Oct 2022 — Present · Hyderabad, IN
Track Wise, GCHS, Complaint Wizard, SmartSolve, JIRA, SAP/ICE/CareLink and Spotfire, PowerBI- End to End Complaint Handling Process- CAPA & Deviation Management- Root Cause Analysis (RCA)- Quality Complaints- Complaint Investigation- SaMD- FDA submissions/reporting (MedWatch FDA Form 3500A, 3500B)- MDR Writer- SmDR / Supplemental- Risk Management (ISO 14971)- Gap Analysis & Remediation- QMS- Standards & Regulations: IMDRF, QMS (ISO 13485, FDA 21 CFR Part 820).
Education
JNTU Anantapur
Doctor of Pharmacy - PharmD
2013 — 2016
KLR (KU)
B.Pharm
2009 — 2013
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