Quality Assurance Executive

1 week ago

Shah Alam, Selangor, Malaysia Zuellig Pharma Full time

Zuellig Pharma is a leading healthcare solutions company in Asia, and our purpose is to make healthcare more accessible to the communities we serve. We provide world-class distribution, digital, and commercial services to support the growing healthcare needs in this region.

The company was started a hundred years ago and has grown to become a multibillion-dollar business covering 17 markets with over 12,000 employees. Our people serve more than 200,000 medical facilities and work with over 450 clients, including the top 20 pharmaceutical companies in the world.

Purpose of the Role: To assist Assistant Manager, Quality Assurance (Validation & Project) in overseeing the compliance with the Company's Quality Management System (QMS) encompassing the company quality policies, relevant ISO, GMP, GDP, GCP, GDPMD, clients' and customers' requirements, and regulatory requirements in Zuellig Pharma Malaysia (ZPMY) and Zuellig Pharma Brunei (ZPBN).

Expectations of the Role:

  • Prepare, review and maintain Validation Master List and Validation Schedule related to passive packaging system and temperature-controlled transport, quality procedures and records to ensure compliance with quality standards and best practices.
  • Ensure validation of passive packaging system and temperature-controlled transport for product deliveries are performed according to approved Protocols and approved Validation Schedule.
  • Review Validation Protocol and Reports of passive packaging system and temperature-controlled transport and ensure they are technically correct and comply with internal and external requirements, local regulatory requirements, Zuellig Pharma Regional QA Procedure Guideline and best practices for ZPMY branches and ZPBN as needed.
  • Develop and maintain Monitoring Schedule with relevant stakeholders in relation to passive packaging system and temperature-controlled transport (e.g. daily local deliveries & outstation long haul deliveries). Review results of the above monitoring activities.
  • Ensure Electronic Data Logging Monitors (EDLMs) are purchased and/or calibrated annually according to approved budgeted timeline. Review calibration log.
  • Review calibration certificates of EDLMs and other critical equipment calibrated by Ops/Facilities team.
  • Prepare or review Annual Risk Assessments for qualification of passive packaging system and temperature-controlled transport.
  • Prepare or review annual Periodic Reviews Report for current in-use passive packaging system and temperature-controlled transport.
  • Review routine validation reports and annual Periodic Reviews for temperature-controlled storage areas as needed.
  • Prepare change control report for implementation of any changes to current in-use approved passive packaging system and transport as per approved SOP and where applicable, support QA Managers with obtaining client approval.
  • Attend and participate in audits (e.g., Client audits/Internal audits/Regulatory audits).
  • Support quality improvement and cross-functional projects that require validation works for ZPMY and ZPBN.
  • Attend, participate, and conduct meetings including cross-functional meetings when needed.
  • Facilitate analysis, creation of reports, forms and graphs for the QA department when needed.

Attributes Required:

Must-Have:

  • Professional bachelor's degree in Quality/ Engineering/ Science
  • 2-3 years of relevant experience
  • Familiar with quality assurance standards, quality risk management and validation management

Advantage to Have:

  • Personal attributes sought are independence, team player, resourcefulness, analytical, initiative, flexibility, and willingness to accept and implement changes.
  • Expected to adopt a hands-on approach at work, with the ability to meet deadlines and requests under tight time constraints.
Seniority level
  • Executive
Employment type
  • Full-time
Job function
  • Quality Assurance
  • IndustriesHospitals and Health Care
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