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Quality Assurance Executive

Full-Time Kuala Lumpur, Malaysia
Health & Biotech
Health & Biotech
02 April 2024
  • Responsible for quality assurance operational activities including managing batch release activities for incoming shipments, local redressing activities, trade returns and write offs, quality related complaints or enquiries and product recall. Work closely with appointed third party service providers and resolve any operational related issues in a timely manner.
  • Responsible for maintaining compliance to the Pharmaceutical Management System (PQS) and Regulatory Compliance System, and supporting compliance activities by driving innovation and continuous improvement

Information and Documentation Management: 

  • Ensure accurate, timely and thorough data entry for Affiliate regulatory activities on relevant Roche systems
  • Manage product information updates with respect to Roche and local regulatory requirements and for Roche databases
  • Ensure files are managed properly and archive documents are complete and easily retrieved
  • Good housekeeping of Quality Assurance areas and inventory, including Filing Rooms
  • Responsible and accountable to ensure SOP is updated as per required on a timely manner
  • Clearance from Quality Assurance Lead is required for all matters related to quality matters, except routine on-going activities


  • Experience in a Quality Assurance role in a pharmaceutical environment for 1-3 years is a plus
  • Knowledgeable in GxP requirements, in particular, GMP, GDP and GDPMD
  • Fluency in written and spoken English and Bahasa Malaysia
  • Proficient in basic computer software/applications

Competencies & Education / Qualifications:

  • Demonstrate Roche Core Competencies
  • Integrity
  • Good analytical, problem-solving and decision making skills
  • Detailed-oriented with a focus on accuracy and precision
  • Builds truthful and effective relationships with stakeholders
  • Commitment to performance measures of time, cost and quality
  • Communication Skills: strong interpersonal skills to influence individuals or groups at more than one level who may have different interests or goals to reach consensus and achieve team objectives.
  • Takes responsibility, drives results and achieves expected outcomes
  • Degree in chemistry or science-related field
  • Trained in GMP, GDP and GDPMD requirements for pharmaceuticals and medical devices


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