Summary
Overview
Work History
Education
Skills
Timeline
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SASIREKHA

Quality Control Microbiologist
JOHOR BAHRU

Summary

Experienced Microbiologist with proven experience improving scientific community by performing accurate research while complying with laboratory safety protocol and standards. Outstanding data management and report development skills contributing to research funding efforts.

Overview

8
8
years of professional experience

Work History

Quality Control Microbiologist

Biocon Biologics
Iskandar Puteri
07.2015 - Current


  • Orchestrated more than 20 microbiological reviews, characterizations, and investigations, establishing expertise in microbiology.
  • Conducted biology experiments on over 3000 samples, identifying and categorizing 2000 bacteria and microorganisms, pivotal in determining contamination sources.
  • Managed comprehensive historical files containing over 3000 microorganisms in specialized areas, including microbial identification and trending.
  • Mentored and trained a team of 5 microbiology associates, comprising 1 temporary employee, 2 permanent employees, and 2 interns, adhering to rigorous good manufacturing practices.
  • Drafted 8 meticulous documents for the development, refinement of laboratory Standard Operating Procedures (SOPs), protocols, and test reports.
  • Successfully investigated 5 instances of non-conformance, involving CAPA and laboratory incident reports, ensuring a 100% resolution rate.
  • Played a pivotal role in various internal and external audits (FDA, EMA, NPRA), contributing as a microbiology process expert in over 10 internal and 20 external audits.
  • Pioneered the execution of 2 change control initiatives, encompassing the integration of new laboratory equipment and system upgrades.
  • Spearheaded the installation of equipment and software, producing 4 comprehensive validation deliverables—System Quality Risk Assessment (SQRA), User Requirement Specification (URS), Design Qualification (DQ), and Performance Qualification (PQ)—within the ValGenesis Validation Lifecycle Management System (VLMS).
  • Established a single Computerized System Validation (CSV) report for 21 CFR Part 11 instruments.
  • Conducted routine/non-routine quality monitoring and testing of utility systems, spanning Purified Water, Water for Injection, and pure steam condensate, on 4 separate occasions.
  • Conducted thorough testing activities, including media receival, sterility checks, and growth promotion tests for general and selective media utilized in testing
  • Collected and analyzed biological data about relationships between organisms and environment.
  • Participated in Cost Reduction project by recycling the schedule waste generated from microbiological lab.


Medical Laboratory Technician

Accufast Diagnostic Laboratory
Kuchai Lama,Kuala Lumpur
04.2015 - 07.2023
  • Maintained strict aseptic fields when collecting biological samples, minimizing staff, and patient infection risks.
  • Utilized expertise in microbiology, chemistry, and hematology to help with diagnosis of medical issues.
  • Maintained confidentiality of all patient information to conform to HIPAA, internal, and other regulatory standards.
  • Prepared reagents and solutions, making readily available during testing for convenience.
  • Participated in laboratory audits and assessments to maintain compliance and improve results.
  • Performed routine maintenance and calibration of laboratory equipment to produce accurate results.
  • Utilized advanced technologies to identify and analyze complex medical samples.
  • Documented and reported equipment malfunctions to supervisor for fast resolution and maintenance.

Education

Associate of Science - Biomedical Sciences

University Science Malaysia
Kubang Kerian, Kelantan
11.2015 - 11.2015

Skills

Standard methods

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Timeline

Associate of Science - Biomedical Sciences

University Science Malaysia
11.2015 - 11.2015

Quality Control Microbiologist

Biocon Biologics
07.2015 - Current

Medical Laboratory Technician

Accufast Diagnostic Laboratory
04.2015 - 07.2023

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SASIREKHA Quality Control Microbiologist