Regulatory Affairs Professional

4 days ago

Shah Alam, Selangor, Malaysia Zuellig Pharma Full time

Zuellig Pharma, a leading healthcare solutions provider in Asia, seeks a Quality Assurance Executive to ensure compliance with our Quality Management System in Malaysia and Brunei. The ideal candidate will oversee the validation of passive packaging systems and temperature-controlled transportation, guaranteeing adherence to quality standards and best practices.

About Us

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

Purpose of This Role:

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

Responsibilities:

  • Validation and Compliance Management: Prepare, review, and maintain validation master lists and schedules for 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 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.

Essential Requirements:

The ideal candidate must hold a professional bachelor's degree in quality engineering science, have 2-3 years of relevant experience, and be familiar with quality assurance standards, risk management, and validation principles.

A suitable candidate should demonstrate strong analytical skills, independence, teamwork, resourcefulness, initiative, flexibility, and a willingness to adapt to changes.

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