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Subang Jaya

    Quality Assurance Executive - Petaling Jaya, Malaysia, Selangor - Abbott

    Abbott
    Abbott Petaling Jaya, Malaysia, Selangor

    Found in: Foundit MY A2 - 4 days ago

    Default job background
    Full time
    Description
    Primary Objective

    Responsible for Quality Management system and to be 100% compliance with Corporate, Divisional and local regulations.

    Core Job Responsibilities

    • Support in developing, implementing, assuring and monitoring the Quality and Regulatory Compliance strategies of the company
    • Supports Complaint Handling/ post market surveillance and follow up actions
    • Assignment of QMS training to employees on quality related documents and policies
    • Preparation of monthly KPI data
    • Provide inputs for Management Review Meeting including updates on adequacy and effectiveness of Quality Management system.
    • Manages the document control for QMS procedures and quality records
    • Support and prepare affiliate for Internal & External Quality & Compliance Audits.
    • Prepare and help to obtain and maintain the GDPMD Certification and/or applicable Quality related certification in the region.
    • Support external, internal and supplier audit and the follow-up remediation plan.
    • Support investigation, defining root-cause and implementation of Corrective Action and Preventive Actions in a timely manner.
    • Execution of Product Stop Shipment, Field Safety Corrective Actions as per instructions from Regional or Divisional QA.
    • Interacts on a periodic frequency with Commercial, Regulatory Affairs, Supply Chain, Technical Service, Education and other functions on all quality related matters.
    • Manage the change control process to meet amendment to local regulatory compliance requirements. OTHER FUNCTIONS AND RESPONSIBILITIES:
    • Perform various administrative functions as required.
    • Any other activities as assigned time to time by Line Manage

    Education/Qualifications/Experience

    • Minimum of Bachelor's degree in Science. Equivalent education/work experience will be considered.
    • Working experience in a Commercial Quality environment in Medical Device or Pharmaceutical organization will be of advantage.
    • Knowledge of local Medical Device regulations
    • Computer proficiency in Word, Excel and PowerPoint.
    • Strong interpersonal skills, with the ability to build and maintain relationships.
    • Effective time management - well organized, able to set and reset priorities
    • Strong oral and written communication skills.
    • Detail and deadline oriented.
    • Conversant local language as well both written and spoken English.
    • Ability to work and flourish in a fast-paced multi-tasked environment
    • Demonstrates a highly positive attitude concerning risk, change and unexpected challenges.
    • Tendency to be friendly, cooperative, agreeable. To be a team person. Promotes the benefits of teamwork and cooperation. Is usually willing to share resources and information.
    • Good in English Communication Skills

    Experience Required

    • Working experience in a Commercial Quality environment in Medical Device or Pharmaceutical organization will be of advantage.
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