Lek Kim Kee
Summary
Leader experienced in pharmaceutical quality assurance and quality control. Well-versed in establishing work priorities to support personnel duties and task to promote quality service and driving continuous improvement and regulatory compliance. Skilled in resource allocation and team collaboration and teamwork. I ensured high-quality standards and operational excellence.
Overview
8
8
years of professional experience
Work History
Section Manager – QA Operations
Novartis Singapore Pharmaceutical Manufacturing Pt
11.2022 - 07.2024
- Oversaw the overall operations (oversight to QC, Logistics, Manufacturing Unit and Supplier Management) to ensure timely delivery of high-quality results with respect to supplier qualification, incoming material release, batch record review, deviation, laboratory investigation, change control, procedure revision and gap assessment.
- Optimized resource allocation by analyzing data trends, forecasting future demands, and adjusting staffing levels accordingly.
- Established key performance metrics to track progress toward organizational objectives, driving continuous improvement efforts.
- Supported team for career growth, building a strong talent pipeline for the organization.
- Fostered a positive work environment by promoting teamwork, open communication, and recognition of individual achievements.
- Evaluated employee performance and provided feedback and training as needed.
- Scheduled regular team meetings to review/discuss key performance metrics, emerging challenges, identify opportunities and recognize employees.
- Conducted internal audit as a lead auditor to ensure adherence to policies, procedures, regulatory requirements and cGMPs. Prepared internal audit reports and reviewed audit response.
- Supported health authority and customer inspections.
Section Manager – Quality System and External QA
Novartis Singapore Pharmaceutical Manufacturing Pt
02.2022 - 11.2022
- Managed and led Quality System and External QA team to achieve department and site objectives in terms of documentation management, supplier qualification and performance monitoring.
- Optimized resource allocation by analyzing data trends, forecasting future demands, and adjusting staffing levels accordingly.
- Tracked key performance metrics to track progress toward organizational objectives.
- Supported team for career growth, building a strong talent pipeline for the organization.
- Fostered a positive work environment by promoting teamwork, open communication, and recognition of individual achievements.
- Evaluated employee performance and provided feedback and training as needed.
- Scheduled regular team meetings to review/discuss key performance metrics, emerging challenges, identify opportunities and recognize employees.
- Drove continuous improvement initiatives.
- Conducted internal audit as a lead auditor to ensure adherence to policies, procedures, regulatory requirements and cGMPs. Prepared internal audit reports and reviewed audit response.
- Supported health authority and customer inspections.
Quality Assurance Manager
Pfizer Asia Manufacturing Pte Ltd
03.2018 - 02.2022
- Provided oversight to Quality Control activities such as laboratory investigation, CAPA, Change Control, equipment qualification, equipment periodic review, procedure creation/revision and gap assessments.
- Reviewed and released Reference Standard Certificate of Analysis (COA) in accordance to the registration specifications and site procedures.
- Managed vendors qualification process.
- Managed learning and training system.
- Trainer of investigation report writing and data integrity trainings.
- Maintained site GMP readiness. Led internal audit as lead auditor and monthly walkdown to ensure adherence to the policies, procedures, regulatory requirements and cGMPs.
- Supported external audits and prepare audit reports.
Quality Systems Manager
Pfizer Asia Manufacturing Pte Ltd
02.2017 - 02.2018
- Managed equipment qualification activities.
- Executed ALCOA assessments, ERES and remediation plans to support global data integrity initiative.
- Reviewed and approval laboratory investigation reports.
- Supported monthly Gemba walk.
- Supported routine operation such as review and approval of Reference Standard data packages.
- Supported internal audits.
Quality Control Specialist
Amgen Singapore Manufacturing
10.2016 - 02.2017
- Supported laboratory readiness activities such as workflow in sample management, waste management, method validation and transfer.
- Completed gap assessments for laboratory equipment and addressed the gaps identified as part of new product transfer.
Education
Bachelor of Science - Chemistry
National University of Singapore
Singapore05.2004
Diploma in Chemical Process Technology With Merit - Industrial Chemistry
Singapore Polytechnic
Singapore05.2000
Skills
- Staff Leadership
- Preventive Maintenance
- Continuous Improvement
- Organizational Development
- Staff Development
- Operations Oversight
- Regulatory Compliance
- Resource Allocation
- Attention to Detail
- Multitasking Abilities
- Team Collaboration
- Decision-Making
- Operating Budgets
- Task Prioritization
- Analytical Thinking
- Quality Assurance
- Report Writing
- Team Management
- Teamwork and Collaboration
- Problem-Solving
- Problem-solving abilities
- Adaptability and Flexibility
- Quality Control Management
Languages
English
Chinese (Mandarin)
Timeline
Section Manager – QA Operations
Novartis Singapore Pharmaceutical Manufacturing Pt
11.2022 - 07.2024
Section Manager – Quality System and External QA
Novartis Singapore Pharmaceutical Manufacturing Pt
02.2022 - 11.2022
Quality Assurance Manager
Pfizer Asia Manufacturing Pte Ltd
03.2018 - 02.2022
Quality Systems Manager
Pfizer Asia Manufacturing Pte Ltd
02.2017 - 02.2018
Quality Control Specialist
Amgen Singapore Manufacturing
10.2016 - 02.2017
Bachelor of Science - Chemistry
National University of Singapore
Diploma in Chemical Process Technology With Merit - Industrial Chemistry
Singapore Polytechnic
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