Quality Assurance Associate

PERSOL; Singapore; On-site; SGD 54,000 - 67,000; Full time

Job summary

PERSOL is seeking an Associate QA to provide on-the-floor quality oversight and operational support in Singapore. You will assist in manufacturing operations, IPC testing, and complex investigations while adhering to cGMP requirements.

The role involves 12-hour onsite shifts with potential day/night rotation, contributing to continuous improvement of Amgen quality systems and collaboration with regulatory inspectors.

Responsibilities

• Responsible for providing oversight for Quality on-the-floor and operations support. The Associate QA will support manufacturing operations and IPC testing through purposeful presence on the floor, as well as support complex manufacturing investigations, change controls, and unexpected result investigations.
• Perform 12-hour onsite shift work, including rotational day and night shifts or permanent night shift arrangements based on business requirements.
• Support the maturation and continuous improvement of Amgen quality systems, including on-the-floor quality oversight, deviation management, and change control, ensuring compliance with cGMP requirements.
• Participate in on-the-floor triage activities and support root cause investigations for major investigations where applicable.
• Review and approve minor deviations, change controls, and other quality records such as electronic batch records, SOPs, logbooks, and work orders.
• Support regulatory inspections and interact directly with regulatory inspectors.
• Support other QA initiatives and activities, including continuous improvement projects, supplier quality management, stability programs, product quality reviews, and customer complaint investigations.
• Escalate significant quality events and issues to Quality Management in a timely manner.

Job description

Key Responsibilities

• Responsible for providing oversight for Quality on-the-floor and operations support. The Associate QA will support manufacturing operations and IPC testing through purposeful presence on the floor, as well as support complex manufacturing investigations, change controls, and unexpected result investigations.

• Perform 12-hour onsite shift work, including rotational day and night shifts or permanent night shift arrangements based on business requirements.

• Support the maturation and continuous improvement of Amgen quality systems, including on-the-floor quality oversight, deviation management, and change control, ensuring compliance with cGMP requirements.

• Participate in on-the-floor triage activities and support root cause investigations for major investigations where applicable.

• Review and approve minor deviations, change controls, and other quality records such as electronic batch records, SOPs, logbooks, and work orders.

• Support regulatory inspections and interact directly with regulatory inspectors.

• Support other QA initiatives and activities, including continuous improvement projects, supplier quality management, stability programs, product quality reviews, and customer complaint investigations.

• Escalate significant quality events and issues to Quality Management in a timely manner.