Quality Assurance Specialist
3 days ago
Zuellig Pharma is a leading healthcare solutions provider in Asia, dedicated to enhancing access to quality healthcare across the region.
About UsWe provide comprehensive distribution, digital, and commercial services to support growing healthcare needs. With a rich history spanning over a century, we have evolved into a multibillion-dollar business operating in 17 markets with over 12,000 employees. Our vast network serves more than 200,000 medical facilities and partners with over 450 clients, including top pharmaceutical companies worldwide.
The Purpose of This Role:
- To assist Assistant Manager, Quality Assurance (Validation & Project) in overseeing compliance with our Quality Management System, encompassing company quality policies, relevant ISO, GMP, GDP, GCP, GDPMD, clients', and customers' requirements, as well as regulatory demands in Zuellig Pharma Malaysia and Brunei.
Key Responsibilities:
- Validation and Compliance: Prepare, review, and maintain Validation Master Lists and Schedules related to passive packaging systems and temperature-controlled transportation, ensuring adherence to quality standards and best practices.
- Ensure validation of passive packaging systems and temperature-controlled transportation for product deliveries are conducted according to approved protocols and schedules.
- Review Validation Protocols and Reports for passive packaging systems and temperature-controlled transportation, verifying their technical accuracy and compliance with internal and external requirements, local regulations, and industry guidelines.
- Monitoring and Calibration: Develop and maintain Monitoring Schedules with relevant stakeholders regarding passive packaging systems and temperature-controlled transportation. Review results from these activities.
- Guarantee Electronic Data Logging Monitors (EDLMs) are purchased or calibrated annually within approved timelines. Examine calibration logs.
- Verify calibration certificates for EDLMs and other critical equipment calibrated by Operations/Facilities teams.
- Risk Assessment and Reporting: Prepare or review Annual Risk Assessments for qualifying passive packaging systems and temperature-controlled transportation. Prepare or review Annual Periodic Reviews Reports for active passive packaging systems and temperature-controlled transportation.
- Review routine validation reports and annual Periodic Reviews for temperature-controlled storage areas when necessary.
- Change Control and Audits: Prepare Change Control Reports for implementing changes to active passive packaging systems and transportation, adhering to approved SOPs and supporting QA Managers with obtaining client approvals, when required.
- Attend and participate in audits, such as client audits, internal audits, and regulatory audits.
- Cross-Functional Support: Support quality improvement and cross-functional projects requiring validation work for Malaysia and Brunei branches.
Essential Attributes:
Mandatory Skills and Qualifications:
- Professional Bachelor's degree in Quality/Engineering/Science.
- 2-3 years of relevant experience.
- Familiarity with quality assurance standards, risk management, and validation principles.
Suitable Candidate Profile:
A suitable candidate should possess independence, teamwork, resourcefulness, analytical skills, initiative, flexibility, and willingness to accept and implement changes.
This role requires adopting a hands-on approach at work, meeting deadlines and requests under tight time constraints, and staying flexible in response to changing priorities and challenges.
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