Pyi Sone Win
Summary
Results-driven Chemist with extensive experience at Alcon Manufacturing, excelling in analytical method validation and regulatory compliance. Proven expertise in managing CAPEX budgets and leading non-conformance investigations. Skilled in laboratory operations and training, leveraging advanced statistical tools to enhance quality control processes. Committed to continuous improvement and technical excellence.
Overview
12
12
years of professional experience
Work History
Chemist
Alcon Manufacturing
08.2013 - Current
- Perform analytical method validation, instrument qualification, and execute re-qualification, re-certification as per schedule.
- Provide prompt technical support for equipment breakdown troubleshooting and diagnostic recovery.
- Manage CAPEX and non-standard project budget, spending forecast, and progress timeline.
- Perform method validation, equipment qualification and upgrade or improvement.
- Ensure QC validations performed are compliant to local SOP, Alcon CORP, FDA, ISO, OSHA, andregulatory requirements.
- Administrate QC computerized system, oversight on user access control, backup and archiving.
- Ensure CSV activities are carried out as planned, include user access review and audit trail review.
- Perform NCR investigation as certified investigator. Provide technical input to the investigation.
- Perform duties as assigned by AS&T manager or designee.
Education
Bachelor of Science - Biomedical Sciences
University of Western Australia
Singapore08-2016
Skills
- Lab operations
- Chemical handling
- Microsoft Excel
- Laboratory techniques
- GMP & GLP
- Non-Conformance Investigator
- Change request coordinator
- Train the trainer
- Basic DI learning
- Advance DI Learning
- Pharmacopeia assessment
- Regulatory gap assessment
- Gage R&R
- KNEAT system
- Statistical Tools (Control Charts, BoxPlots)
Languages
English
Bilingual or Proficient (C2)
Malay
Bilingual or Proficient (C2)
Thai
Beginner (A1)
Timeline
Chemist
Alcon Manufacturing
08.2013 - Current
Bachelor of Science - Biomedical Sciences
University of Western Australia
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