Pharmaceutical Quality Control Manager

3 days ago

Shah Alam, Selangor, Malaysia Zuellig Pharma Full time

Zuellig Pharma is a prominent player in the Asian healthcare landscape, committed to making high-quality healthcare accessible to communities across the region. Our company provides end-to-end healthcare solutions that include distribution, digital, and commercial services tailored to meet the diverse needs of our clients.

About Us

We boast a rich history spanning over a century, having grown from humble beginnings to become a multibillion-dollar business with operations in 17 markets and over 12,000 employees. Our extensive network reaches over 200,000 medical facilities and collaborates with more than 450 clients, including some of the world's top pharmaceutical companies.

Purpose of This Role:

  • To assist the Assistant Manager, Quality Assurance (Validation & Project), in ensuring compliance with our Quality Management System, which encompasses company policies, relevant standards (ISO, GMP, GDP, GCP, GDPMD), client and customer requirements, as well as regulatory requirements in Malaysia and Brunei.

Responsibilities:

  • Validation and Compliance Management: Prepare, review, and maintain master lists and schedules for validation of 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 is performed according to approved protocols and schedules.
  • Review validation protocols and reports for passive packaging systems and temperature-controlled transportation, ensuring they are technically accurate and compliant with internal and external requirements, local regulations, and industry guidelines.
  • Equipment Calibration and Maintenance: Develop and maintain monitoring schedules with relevant stakeholders for 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. Review calibration logs.
  • Verify calibration certificates for EDLMs and other critical equipment calibrated by Operations/Facilities teams.
  • Risk Assessment and Periodic Reviews: Prepare or review annual risk assessments for qualifying passive packaging systems and temperature-controlled transportation. Prepare or review annual periodic reviews reports for current in-use 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 Audit Support: Prepare change control reports for implementing changes to current in-use passive packaging systems and transportation, adhering to approved SOPs and supporting QA managers with obtaining client approvals when required.
  • Attend and participate in audits, including client audits, internal audits, and regulatory audits.
  • Cross-Functional Collaboration: Support quality improvement and cross-functional projects requiring validation work for Malaysia and Brunei branches.

Required Skills and Qualifications:

Mandatory attributes include professional bachelor's degree in quality engineering science, 2-3 years of relevant experience, and familiarity with quality assurance standards, risk management, and validation principles.

A successful candidate will demonstrate strong analytical skills, independence, teamwork, resourcefulness, initiative, flexibility, and willingness to adapt to changes.

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