Sri Wahyuni Al
Overview
23
23
years of professional experience
Work History
Microbiologist/Lab Supervisor/Lab Manager/Snr Quality Manager/Quality Director
Edwards Lifesciences
01.2006 - Current
- Leadership and Training: Led, supervised, and trained a team of microbiologists, chemists, laboratory technologists, and technicians. Managed resources and projects for the Quality Laboratory (Microbiology and Chemistry).
- Facility Setup and Validation: Provided microbiological and chemistry oversight for facility validation activities. Successfully coordinated and executed validation activities (IQ/OQ/PQ) for critical systems such as Controlled Environment, Process Water System, Compressed Air System, and Solutions Systems within tight deadlines.
- Manufacturing Equipment Validation: Developed validation strategies for manufacturing equipment, focusing on bioburden reduction processes and sterilization. Reviewed and approved data and protocols to ensure compliance with global procedures and regulatory standards.
- Laboratory Equipment and Test Method Transfers: Established protocols for the validation (IQ/OQ/PQ) of laboratory equipment and test method transfers, enhancing testing capabilities for routine operations and product release.
- Compliance and Protocol Review: Reviewed and approved protocols and procedures written by laboratory personnel to ensure compliance with Edwards Global Procedures and ISOs.
- Laboratory Investigations and CAPA Management: Conducted, wrote, and reviewed laboratory investigations (OOS/OOT/CAR) and managed CAPA for critical systems or laboratory-related failures or variances.
- Internal Quality Audits (IQA): Extended responsibilities in the areas of IQA for approximately one year.
- Career Highlights:
- ISO Standards Knowledge: Proficient in ISO13485, ISO14644, and ISO14160 standards for medical devices, controlled environments, and liquid sterilization.
- Qualified ISO 9001 Lead Auditor: Involved in supplier qualification through site audits.
- Team Leadership and Succession Planning: Led and coordinated a team to perform roles and tasks efficiently and effectively. Developed succession plans for the team.
- Data Review and Compliance: Reviewed datasheets and associated documents to ensure compliance with procedures, standards, GMP, and GDP for routine and validation activities.
- Regulatory Audits: Acted as a Subject Matter Expert (SME) in regulatory audits (Internal/Corporate/FDA/TUV/DEKRA), achieving no major non-conformances from a laboratory perspective over 15 years.
- Cross-Functional Collaboration: Collaborated with cross-functional departments to address issues, concerns, and product non-conformances, minimizing operational downtime.
- Facility Expansion: Successfully validated facility expansion while managing routine activities within tight budgets and timelines.
- LEAN Principles: Planned and designed new Micro & Chemistry Lab layouts with LEAN principles in mind.
- Business Excellence Projects: Participated in Business Excellence Projects, establishing KANBAN System, 6S, Visual Boards for Performance Management, and Leaders Standard Work (LSW).
Quality Microbiologist
Schering Plough Ltd
01.2002 - 01.2006
- Environmental Monitoring: Conducted environmental monitoring (air, surfaces, swabs) for routine, batch-related processes, and qualifications in clean rooms and production areas.
- Water Sampling and Testing: Performed water sampling and testing (purified, feed, pretreatment, PUB) for routine, batch-related processes, and qualifications for water systems.
- Automated System Validation: Wrote protocols for the validation (IQ/OQ/PQ), calibration, and operation of automated systems such as VITEK and MIDI GC for routine identification tests.
- Micro Limits Testing: Conducted USP/JP/EP Micro Limits Testing (MLT) for active pharmaceutical ingredients, final drug substances, and excipients.
- Growth Promotion Tests (GPT): Performed GPT and sterility checks for all incoming media used for testing, including media and reagent preparations.
- Quality Control: Conducted QC checks for consumables, reagents, test kits, and ATCC microorganisms.
- Microorganism Identification: Identified microorganisms in water, environment, and product samples using Gram stain, supplementary tests, API kits, VITEK, and MIDI GC System.
- Career Highlights:
- Team Leadership: Led and coordinated a team to perform roles and tasks efficiently and effectively, ensuring timely testing of samples.
- Documentation Support: Wrote and revised SOPs and protocols, ensuring compliance with procedures, GDP, and GLP.
- Workflow Improvement: Streamlined and improved current workflows in accordance with Level II standards and pharmacopeias.
- Continuous Improvement Projects: Actively involved in continuous improvement projects.
- Trend Reporting: Prepared water and environmental systems trend reports for respective facilities.
- Inventory Control: Maintained inventory control, ordering, budgeting, soliciting quotations, and purchasing laboratory consumables. Liaised with vendors for product purchases and training programs.
- Personnel Training: Trained personnel in various laboratory aspects and testing.
- Laboratory Investigations and CAPA: Conducted and wrote laboratory investigations and CAPA for product, test, batch, or laboratory-related failures or variances.
- Regulatory Audits: Participated in internal and external audits by regulatory bodies.
Education
Bachelor Degree of Science - Biotechnology
Monash University
Diploma - Educational Studies – Enrichment Enterprise
The College of Teachers, UK, GIG Education Centre
Diploma - Applied Psychology
Southern Cross College
Diploma - Biotechnology
Singapore Polytechnic
Skills
- Proficient in computer applications
- Microsoft Office proficiency
- Qualities and Strengths
- Good communication skills
- Effective collaboration with cross-functional teams
- Independent work proficiency
- Meticulous and outcome-driven
Languages
Fluent in English and Malay (Written and Spoken)
Timeline
Microbiologist/Lab Supervisor/Lab Manager/Snr Quality Manager/Quality Director
Edwards Lifesciences
01.2006 - Current
Quality Microbiologist
Schering Plough Ltd
01.2002 - 01.2006
Diploma - Applied Psychology
Southern Cross College
Diploma - Biotechnology
Singapore Polytechnic
Bachelor Degree of Science - Biotechnology
Monash University
Diploma - Educational Studies – Enrichment Enterprise
The College of Teachers, UK, GIG Education Centre
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