SENIOR MANAGER - QUALITY ASSURANCE, OPERATIONS

Hartalega


Date: 1 week ago
City: Sepang
Contract type: Full time
Company Overview

Leading Growth Through Innovation

As the World's No.1 Nitrile Glove manufacturer, Hartalega is currently in the process of recruiting a diverse pool of talented people, across various specialisations and backgrounds. You will enjoy exceptional benefits and incentives, as well as a well-defined path for career success.

Hartalega is made up of a tight-knit, passionate and highly-skilled set of individuals. From our top executives, to our line technicians; we are all proud to be part of an elite group responsible for revolutionising the glove-making industry.

Overview

Job Description

  • 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

Additional Company Information

Registration No. Company Size

75398-K More than 5000 Employees

Average Processing Time Industry

21 days Manufacturing / Production

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