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Role reports to：
Make Quality Lead - Malaysia位置：
Asia Pacific, Malaysia, Selangor, Petaling Jaya工作地點：
完全現場你會做什麼
To provide overall quality support for Quality System activities, implemented from product development through to commercialization and distribution, in the manner that complies with Regulatory, GMP, Safety Health and Environment and corporate quality standard. Ensure all projects are executed, validated and well documented to ensure compliance with cGMP & Kenvue policy.
1. Leadership & Kenvue-Way Behaviors
Demonstrate integrity and model Kenvue-Way actions in all activities.
Apply strategic thinking with strong attention to detail and big-picture awareness.
Collaborate effectively across teams with a sense of urgency and accountability.
Exhibit intellectual curiosity, adaptability, self-awareness, and a results-driven mindset.
2. Quality Systems & Compliance Management
Develop, implement, maintain, and continuously improve Quality Management Systems (QMS) supporting product development, manufacturing, and release.
Maintain continuous audit and inspection readiness of the manufacturing site.
Administer and support QMS platforms, including NC, CAPA, documentation and records systems, and the Learning Management System (LMS).
Ensure GMP documentation, specifications, and manufacturing work instructions are accurate, current, and controlled.
Ensure compliance with SOPs, Good Documentation Practices (GDP), and Data Integrity requirements.
Track documentation and record status to ensure timely revision, closure, and reconciliation.
Support and lead global and local quality initiatives, improvement projects, and Kenvue Production System activities.
Support the site’s Indirect Supplier Management program, including supplier qualification, approved supplier list management, quality agreements, and performance monitoring.
3. Microbiology Operations & Testing
Prepare and qualify microbiological media, including pH, sterility, fertility, and growth promotion testing.
Maintain stock cultures and perform microorganism identification.
Conduct plant hygiene and environmental monitoring, including water, air, compressed air, and post-CNS monitoring, with defined sampling plans and trending.
Perform end-to-end microbial limit testing for raw materials, bulk, and finished products, including incubation, result reporting, and batch micro release.
Perform and support microbiology-related OOS investigations for facilities, materials, products, and components.
Support hygiene- and MRA-related change management initiatives involving personnel, facilities, equipment, and validation.
4. Equipment Qualification & Maintenance
Perform laboratory equipment qualification and annual equipment reviews.
Manage equipment calibration and preventive maintenance programs according to schedule.
Investigate equipment-related issues, including calibration out-of-limit (OOL) and environmental monitoring failures.
5. Laboratory Purchasing & Inventory Management
Manage procurement of laboratory chemicals and consumables.
Coordinate laboratory inventory levels and stock availability.
Liaise with external suppliers regarding purchasing, availability, and payment.
Support laboratory budget tracking and cost management.
6. Continuous Learning & Team Development
Stay current with new technologies and best practices through collaboration with Kenvue affiliates and originating companies.
Build strong technical knowledge of products and materials to support new product introductions and improvement projects.
Provide coaching, mentoring, and technical guidance to new team members.
7. GLP, GMP & EHS Compliance
Ensure adherence to GLP, GMP, and EHS policies and laboratory regulations.
Maintain clean, safe, and orderly laboratory workstations in line with company requirements.
What We Are Looking For
Required Qualifications
Bachelor’s degree in Microbiology, Biology, Chemistry, or a related scientific discipline.
Experience in microbiology and quality systems within a GMP manufacturing environment.
Strong knowledge of GMP, GLP, GDP, Data Integrity, and Quality Management Systems.
Hands-on experience in environmental monitoring, microbiological testing, and OOS investigations.
Experience with electronic QMS and documentation control systems.
Strong analytical skills, attention to detail, and ability to manage multiple priorities.
Effective communicator with the ability to collaborate across functions.
Preferred Qualifications
Experience in a multinational or regulated FMCG/pharmaceutical manufacturing environment.
Exposure to regulatory inspections, audits, and continuous improvement initiatives.
Experience supporting training systems, supplier quality, and equipment qualification.
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