Commercial Quality Executive (Pharma)

People Profilers; Singapore; On-site; SGD 45,000 - 75,000; Full time

Job summary

An established industry player is seeking a dedicated Quality Assurance professional to support commercial operations across the Asia Pacific. This role involves ensuring compliance with Good Distribution Practice and maintaining the Quality Management System documentation. You will collaborate with cross-functional teams, manage audits, and oversee quality incidents to ensure product safety and quality during transit. The successful candidate will enjoy a competitive remuneration package and a comprehensive range of benefits, making this an excellent opportunity for those passionate about quality assurance in the pharmaceutical sector.

Qualifications

• Bachelor's degree in Pharmaceutical Science or equivalent knowledge.
• Quality experience in the industry and application of Quality Systems.

Responsibilities

• Support commercial operations and ensure compliance with Good Distribution Practice.
• Maintain documentation for the Quality Management System and manage audits.

Skills

Interpersonal Skills

Problem Identification and Solving

Communication Skills

Adaptability

Service Mind

Education

Bachelor's Degree in Pharmaceutical Science

Tools

SAP

Job description

• Provides support to commercial operations in Asia Pacific to releasing in-bound shipment from the manufacturing sites to the markets.
• Ensure that appropriate standard of Good Distribution Practice (GDP) in relation to the transportation of products, including environmental parameters are monitored in accordance with the requirements of EU directive and regulations of the markets supplied.
• QA operations. Establish and maintain documentation to support the Quality Management System (QMS) for company (local and international). Remain abreast with the QMS relevant to the operation at company. Assist the preparation and review of Quality Technical Agreement (QTA) and coordinate with other parties as assigned by Quality Director.
• Ensure that valid licenses from suppliers, warehouse and distributors are received and maintained. Download and review temperature records of each shipment (or obtain download records from warehouse/distributor).
• Release in-bound shipments as per the criteria agreed with suppliers.
• Co-ordinate with CMO-contact or Supply team for the case of documentation errors or temperature excursion or other incidents that may impact product quality/safety during transit.
• Carry out duties in compliance with QMS and CMO (Contract Manufacturing Operation) management.
• Create, update and maintain SAP database in relation to quality areas.
• Ensure timely and effective escalation of quality incidents to Quality Director.
• Maintain HSA licenses and responsible for Singapore's HSA audits. Support GDP's regulatory audits in SEA upon receiving request. Audit new distributors and renewal audits as per schedule. Manages and oversees the audit schedule, working with regional audit team to ensure that suppliers and contract manufacturers have been audited.

Requirements

• Bachelor's Degree in Pharmaceutical Science or able to demonstrate equivalent level of knowledge.
• Quality experience within the industry, and application of Quality Systems.
• Experience of 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 adapt to different working cultures.
• Able to commit to business travel if required.

All Successful candidates can expect a very competitive remuneration package and a comprehensive range of benefits.

We regret that only shortlisted candidates will be notified.