ASSISTANT MANAGER - QUALITY ASSURANCE, LAB

Job Description

OVERVIEW

• The incumbent is responsible to assist QA Manager to oversee and manage in process inspection activities, incoming latex, chemicals, and Finished-product laboratory testing. The incumbent is to ensure that procedures and work instructions are being implemented accordingly and test results would supplement the market release disposition at Pre-Shipment Inspection stage.
  
  

DUTIES AND RESPONSIBILITIES

Business/ Operations

• Monitoring and controlling resources and overseeing the spending of money within budget
• Communicating technical information (oral and written)
• Implementing policies, standards, and procedures for Lab
• Managing quality testing, release control and documentation
• Conducting tests and inspections of products, or processes to evaluate quality or performance
• Investigating quality issues, and developing resolutions
• To lead, manage and control on daily incoming and in-process inspection in the laboratories including microbiological laboratory.
• Check and identify on any deviations in procedure and work instruction against actual practice in laboratory.
• Establish, create, review, update and manage lab related documentation to ensure its accuracy and validity, this includes:
  • Standard Operating Procedures
  • Work Instructions
  • Forms, Tables and OPL
• To organize and oversee the laboratory activities by ensuring testing method / instructions established are being implemented successfully as per current standards:
  • AQL set forth
  • Industry Standard Organization Testing method
  • Regulatory Requirements
  • ISO documentation and testing method.
    
    

People/ Stakeholder Management

• Leading a team of engineers, and executives preferably for a medium to large-scale manufacturing organization 
• Navigating multiple stakeholders within the organization to achieve results. Organize a quality review and improvement with stakeholders whenever require, with timely completion on agreed action plan.
• To update stakeholders on the quality status of affected material and progression of both containment and permanent solution.
• Building cooperative working relationships within the organization
• Building enduring relationships with key customers
  
  

Other

• Any other task / project as assigned by the superior and management.
  
  

REQUIREMENTS

Education:

• Bachelor’s Degree in Science or any related field.
  
  

Work Experience:

• Minimum 5 years of working experience with similar roles and responsibilities in analytical testing laboratory preferably in chemical or medical devices industries.
  
  

Technical and Professional Knowledge:

• Sound knowledge in Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Sound knowledge in FDA QSR requirements as per 21 CFR 820 and ISO Standards & requirements particularly ISO 13485, ISO 9001, and ISO 17025.
• Strong knowledge of Corrective Action and Preventive Action (CAPA) processes and Root Cause Analysis (RCA) and problem-solving techniques.
• Strong knowledge of laboratory processes and operations management.
• Project management principles, data analyses and reporting.
• Work planning and scheduling; inclusive of operational and manpower planning.
• Analytical method development and validation include test method development and test method validation.
  
  

Certification / License Requirement:

• N/A