Summary
Overview
Work History
Education
Skills
Languages
Personal Information
References
Timeline
Generic
Udani Thilakarathne

Udani Thilakarathne

Ratmalana

Summary

I am a Bachelor in Pharmacy Graduate of Sri Lanka, and registered Pharmacist at Sri Lanka Medical Council since 06/08/21. I am currently working as a Regulatory Affairs Officer at State Pharmaceutical Manufacturing Corporation, Ratmalana. My current endeavor is to apply for a regulatory affairs job overseas and look for job opportunities that match my qualifications.

Overview

5
5
years of professional experience

Work History

Regulatory Affairs Officer

State Pharmaceuticals Manufacturing Corporation
10.2022 - Current
  • Worked with governance committees to make and evaluate plans.
  • Performed and documented quality control checks to maintain compliance with company initiatives.
  • Recommended improvements to processes.
  • Assisted with regulatory product compliance initiatives such as Change controls and Quality Management Systems.
  • Prepared and maintained document inventory for core dossier preparation.
  • Prioritized project-related tasks to efficiently complete essential tasks.
  • Adhered to state and federal requirements for National Medicines Regulatory Authority, Sri Lanka registrations.
  • Managed all regulatory needs for products such as oral solid dosage forms such as general drugs,hormonal drugs and Penicillin drugs .
  • Provided responses to regulatory agencies(NMRA) regarding product information or issues.
  • Managed fees and applications, tracked product progress and handled all responses to regulatory inquiries.
  • Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.
  • Consulted with regulatory representatives to manage filings, applications, and reports.
  • Developed strong communication and organizational skills through working on group projects.

QA Officer

CELOGEN LANKA PVT. LTD
09.2020 - 03.2021
  • Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
  • Reviewed production processes and identified potential quality issues.
  • Reviewed and validated quality requirements for manufacturing planning, supplier purchase orders, and engineering specifications to meet contract compliance regulations.
  • Reported problems and concerns to management.

Pharmacy Assistant

N K D Pharmacy
05.2019 - 06.2019

Education

Postgraduate Diploma - Health Development

University of Colombo
Colombo ,Sri Lanka

Bachelor of Pharmacy - Pharmacy

University of Jaffna
Jaffna ,Sri Lanka
01.2020

Advanced Level Examination - Biological Stream

Seethadevi Girls' College
Kandy ,Sri Lanka
01.2014

Skills


  • Communications
  • Information Technologyy
  • Pharmacology
  • Pharmacy Practices
  • Tamil Languages
  • Hospital Pharmacy
  • Health Sciences
  • Regulatory Policies
  • Regulatory Submissions
  • Depositions
  • Risk Management
  • ISO Standards
  • Documentation Management
  • Product Information
  • SAP EHS Management
  • Global Regulatory Compliance
  • Inspections
  • Requests for information
  • Document Management
  • Technical Writing

Languages

English
Tamil

Personal Information

  • Date of Birth: 05/19/93
  • Nationality: Sinahalese
  • Marital Status: Married
  • Visa Status: Not Applied yet

References

  • Mr. P. Kalki, kalkisp@yahoo.com, 0773913766
  • Mr Haresh Bhor, +9170381 16344

Timeline

Regulatory Affairs Officer

State Pharmaceuticals Manufacturing Corporation
10.2022 - Current

QA Officer

CELOGEN LANKA PVT. LTD
09.2020 - 03.2021

Pharmacy Assistant

N K D Pharmacy
05.2019 - 06.2019

Postgraduate Diploma - Health Development

University of Colombo

Bachelor of Pharmacy - Pharmacy

University of Jaffna

Advanced Level Examination - Biological Stream

Seethadevi Girls' College

Similar Profiles

CREATE PROFILE
Udani Thilakarathne