ASSISTANT MANAGER - QUALITY ASSURANCE, LAB

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.

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

• 
  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
  Additional Company Information
  Registration No. Company Size
  75398-K More than 5000 Employees
  Average Processing Time Industry
  21 days Manufacturing / Production

Work Planning, Validation, Reporting, iso standards, Operations Management, Scheduling, Root Cause Analysis