Job Description

OVERVIEW

• The incumbent is responsible to manage and oversee quality assurance operations and/or inspection at both plants based at Bestari Jaya and Sepang in relation to Incoming, In-process, Final inspection, and Validation / Calibration. Responsible in managing operational costs and budgets of the department.
  
  

DUTIES AND RESPONSIBILITIES

Business/ Operations

• Managing operational costs and budgets
• Managing product quality to ensure compliance with quality policies, procedures and regulations
• Supervising and coordinating the manufacturing quality assurance, equipment/process calibrations/validations, compliance/documentation, microbiology and quality control activities
• Developing solutions for troubleshooting analytical methods. Leading continuous process and quality improvements.
• Identifying non-conformance trends, developing and implementing technical investigations, and initiating corrective actions
• Implementing preventative measures to reduce shipment failure, customer complaints and improve overall product quality
• Manage and oversee QA incoming, in-process and final inspection processes supported by QA Managers at both sites.
• Manage validation and calibration program. Ensure complete, effective, and efficient.
• Ensure processes developed are clearly defined with the WI/ Procedure/OPL, SOJT and Workflow.
• In regards to the processes under work scope, special focus on the following:
  • Review and improve documentation in (1 and 2) for accuracy and completeness and fit for purpose
  • Ensure clarity in requirements and specifications which is clear to all stakeholders
  • Ensure clear workflow, PICs and escalation with identified lead time to ensure acceptable response time
  • Review and seek discussion on structure of QA operations to improve effectiveness and efficiency of operations and services
  • Generate reports on process and product capabilities using Statistical Process Control
  • Efficient use of resources
• Propose, cascade and execute KPIs which support Corporate KPIs and goals
  
  

People/ Stakeholder Management

• Leading operations teams preferably for a medium to large-scale manufacturing organization with more than 100 direct or indirect staff.
• Ensure manpower in all levels of QA operations are clear on role & responsibilities and are well trained in skills and knowledge.
• Working in a complex organization, navigating and influencing multiple stakeholders to achieve results
  
  

REQUIREMENTS

Education:

• Bachelor Degree and/or Masters in Engineering and Science.
  
  

Work Experience:

• Minimum 10 years of working experience in a manufacturing environment with 4 years in a managerial post.
  
  

Technical and Professional Knowledge:

• Good Manufacturing Practices (GMP) and Good Laboratory Practice (GLP).
• Quality Management Systems related to Medical Devices i.e. FDA QSR requirements as per 21 CFR 820, ISO 2859 Sampling Procedures for Inspection, ISO 13485: QMS, ISO 14971: Risk Management Assessment and ISO 9001.
• Knowledge of Corrective Action and Preventive Action (CAPA) processes and Root Cause Analysis (RCA).
• Lean manufacturing concepts and operational excellence methods and practices.
• Work planning and scheduling; inclusive of operational and manpower planning.
  
  

Certification / License Requirement:

• N/A