Commercial Quality Assurance Specialist

3 weeks ago

Singapore PEOPLE PROFILERS PTE. LTD. Full time
{"Roles & Responsibilities": "Key Responsibilities

As a Commercial Quality Executive at People Profilers Pte. Ltd., you will be responsible for ensuring the quality of commercial operations in Asia Pacific. This includes releasing in-bound shipments from manufacturing sites to markets, monitoring Good Distribution Practice (GDP) standards, and maintaining documentation to support the Quality Management System (QMS).

  • Provide support to commercial operations in Asia Pacific to ensure the quality of in-bound shipments.
  • Ensure that appropriate standards of GDP are monitored in accordance with EU directives and market regulations.
  • Establish and maintain documentation to support the 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 as per agreed criteria with suppliers.
  • Coordinate with CMO contacts or Supply teams for 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.

A competitive remuneration package and comprehensive benefits await the successful candidate.

People Profilers Pte. Ltd. is an equal opportunities employer.

Tell us about your skills

Quality Management
Operations
Interpersonal Skills
Company Commercial
Business Travel
Problem Identification
SAP
Compliance
Transportation
Audits
Commercials
Commercial planning
Manufacturing
Audit

"}

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