Dynamic individual with hands-on experience in management of laboratory and talent for navigating challenges. Brings strong problem-solving skills and proactive approach to new tasks. Known for adaptability, creativity, and results-oriented mindset. Committed to making meaningful contributions and advancing organizational goals.Versatile professional, open to exploring diverse roles and industries to foster career growth. Eager and ready to take on new challenges and contribute effectively in any capacity
Overview
7
7
years of professional experience
1
1
Certification
Work History
Microbiologist II
Boston scientific Medical Devices
01.2022 - Current
Handling of manpower by allocating defined responsibilities to the team members.
Ensure quality and integrity of test data generated from finished product, raw material, calibration, qualification and validation studies.
Ensure compliance with current Good Laboratory Practice (GLP) standards, including auditing activities by coordinating with QMS department.
Create and revise Work Instructions for the laboratory use.
Raising NCEP and perform investigations
Laboratory software development and validation (Pyros eXpress)
LIMS software development for laboratory documentation processes
PCA drafting for projects requirements.
Test Method Validation for new Products
Test Method Verification on established products.
Involve in Audits as Subject Matter Expert of Sustaining Products (Internal Audits, BSI Audits, Dekra Audits)
Establish protocols for validations
Execute Validations on the new products, software
Involve in Sterilization Process (E-beam, ETO, Gamma)
Be a part of problem solving team
Be a part in laboratory testings (Bioburden, Endotoxin,Environmental Monitoring)
Be a part in new cleanroom set up & qualifications
Maintain dunnage for
Optimized lab workflow by training junior staff members on proper equipment usage, sample handling, and data recording practices.
Ensured compliance with regulatory standards by maintaining detailed records of laboratory procedures and results.
Interpreted research findings and summarized data into reports.
Managed overall laboratory functions.
Increased accuracy of test results through meticulous attention to detail during data analysis and interpretation.
Assisted in the development of new laboratory protocols, resulting in increased efficiency and cost savings.
Scheduled and trained technical staff members.
Reduced contamination risk by maintaining a sterile laboratory environment and adhering to safety protocols.
QC SR. MICROBIOLOGIST
SM PHARMACEUTICALS SDN BHD
11.2017 - 12.2022
Mentored junior microbiologists, building a collaborative and high-performing team.
Established rigorous quality control measures to maintain accuracy and reliability of test results.
Developed new microbial assays for faster detection of pathogens, improving turnaround times.
Evaluated emerging technologies in microbiology, making recommendations for strategic investments to keep the laboratory at the forefront of industry advancements.
Increased laboratory safety by developing comprehensive risk assessments for handling hazardous materials.
Identified root causes of contamination incidents, implementing corrective actions to prevent future occurrences.
Maintained strong relationships with vendors, negotiating contracts that secured cost-effective supplies without compromising quality or delivery timelines.
Streamlined communication between departments by serving as a liaison between microbiology teams and other functional areas within the company.
Played an instrumental role in troubleshooting and resolving equipment malfunctions, minimizing downtime in the lab.
Designed and executed successful validation studies for new testing methods, ensuring regulatory compliance.
Enhanced laboratory efficiency by streamlining sample processing and testing procedures.
Collaborated with cross-functional teams in the development of new products, contributing valuable microbial insights.
Led a successful initiative to reduce waste in the lab, decreasing environmental impact as well as operational costs.
Provided critical support during audits by presenting data effectively and addressing any concerns raised by auditors.
Conducted training sessions on proper lab techniques for non-microbiology staff members, ensuring adherence to best practices throughout the organization.
Managed overall laboratory functions.
Scheduled and trained technical staff members.
Ordered laboratory equipment and supplies.
Interpreted research findings and summarized data into reports.
Encouraged cooperative management strategies.
Managed autoclave validations
Responsible for conducting training to new joiners and maintain the training records as per the procedure
Responsible in report reviewing, deviations
Involved in preparation, review and execution of study protocols and laboratory test data.
Business System Analyst III at Boston Scientific Medical Device (Malaysia) Sdn. BhdBusiness System Analyst III at Boston Scientific Medical Device (Malaysia) Sdn. Bhd