Commercial Quality Assurance Specialist

2 days ago

Singapur, Singapore People Profilers Full time

Job Summary

We are seeking a highly skilled Commercial Quality Executive to join our team at People Profilers. As a key member of our commercial operations team, you will be responsible for ensuring the quality of our products and services in the Asia Pacific region.

Key Responsibilities

  • Provide support to commercial operations in Asia Pacific to ensure the quality of in-bound shipments from manufacturing sites to markets.
  • Ensure that appropriate standards of Good Distribution Practice (GDP) are maintained in relation to the transportation of products, including environmental parameters, in accordance with EU directives and market regulations.
  • Establish and maintain documentation to support the Quality Management System (QMS) for the company, both locally and internationally.
  • Assist in the preparation and review of Quality Technical Agreements (QTAs) and coordinate with other parties as assigned by the Quality Director.
  • Ensure that valid licenses from suppliers, warehouses, and distributors are received and maintained.
  • Release in-bound shipments in accordance with agreed-upon criteria with suppliers.
  • Coordinate with CMO contacts or Supply teams in case of documentation errors, temperature excursions, or other incidents that may impact product quality or safety during transit.
  • Carry out duties in compliance with QMS and CMO management.
  • Create, update, and maintain SAP databases related to quality areas.
  • Ensure timely and effective escalation of quality incidents to the Quality Director.
  • Maintain HSA licenses and be responsible for Singapore's HSA audits. Support GDP's regulatory audits in SEA upon request. Audit new distributors and renewal audits as per schedule.

Requirements

  • Bachelor's Degree in Pharmaceutical Science or equivalent level of knowledge.
  • Quality experience within the industry, with application of Quality Systems.
  • Experience working with cross-site and multi-functional teams.
  • Strong interpersonal skills.
  • High sense of urgency and service mind.
  • Excellent oral and written communication skills.
  • Problem identification and solving skills.
  • Resilient and adaptable to different working cultures.
  • Able to commit to business travel if required.

What We Offer

A very competitive remuneration package and a comprehensive range of benefits.

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