Associate Director Analytical Services @ (November 2021 - February 2025)
Director Global Quality Systems @ (August 2019 - July 2020)
Director Global Quality Systems, Documentation and Training @ (August 2019 - August 2019)
Head Of Quality @ (February 2017 - April 2019)
Director Quality Systems @ (November 2010 - February 2017)
Principal Consultant @ MFL Pharma Quality Compliance (February 2009 - November 2010)
Director Quality Systems @ (March 2007 - February 2009)
Director Quality Systems @ (November 2003 - March 2007)
Michele Lim Education
University of South Australia
Michele Lim Skills
GMP
FDA
Quality Assurance
Pharmaceutical Industry
Biotechnology
Quality System
Change Control
Validation
Regulatory Affairs
SOP
Microbiology
Technology Transfer
Regulatory Submissions
Analytical Chemistry
21 CFR Part 11
CAPA
Quality Control
Medical Devices
U.S. Food and Drug Administration (FDA)
Standard Operating Procedure (SOP)
Corrective and Preventive Action (CAPA)
Good Manufacturing Practice (GMP)
Technical writing
Cross-functional Team Leadership
Staff Development
GxP
Computer System Validation
Analytical Method Validation
Data Integrity
Aseptic Manufacturing
Risk Management
Windows
Work Effectively
Office 365
Spreadsheets
Microsoft Excel
Laboratory Systems
VEEVA Quality Docs
General Data Protection Regulation (GDPR)
MS Teams
ZOOM
Personal Development
Emotional Intelligence
Constructive Feedback
Career Management
Leadership
LinkedIn Learning
Michele Lim Summary
Michele Lim, based in Scotch Plains, NJ, US, is currently a Associate Director at Ardena. Michele Lim brings experience from previous roles at MFL Pharma Quality Compliance, Catalent Pharma Solutions, Bristol Myers Squibb and Celgene. Michele Lim holds a University of South Australia. With a robust skill set that includes GMP, FDA, Quality Assurance, Pharmaceutical Industry, Biotechnology and more. Michele Lim has 2 emails and 2 mobile phone numbers on RocketReach.
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