Quality Assurance Associate

PERSOL SINGAPORE PTE. LTD.; Singapore; Vor Ort; SGD 52.000 - 75.000; Vollzeit

Zusammenfassung

PERSOL Singapore is seeking an Associate QA to provide on-the-floor quality oversight and support manufacturing operations and IPC testing. This role involves 12-hour onsite shifts with possible rotation day/night or permanent night arrangements, ensuring adherence to cGMP and quality systems.

You will participate in triage activities, support root cause investigations for major events, and review deviations, change controls, and quality records while interacting with regulatory inspectors and

Aufgaben

• Provide on-the-floor oversight for quality and support manufacturing operations and IPC testing.
• Support 12-hour onsite shifts with rotational day/night or permanent night arrangements.
• Mature Amgen quality systems including deviation management and change control per cGMP.
• Participate in on-the-floor triage activities and assist root cause investigations for major issues.
• Review and approve minor deviations, change controls, and quality records (e-files, SOPs, logs, work orders).
• Support regulatory inspections and interact with inspectors.
• Contribute to continuous improvement initiatives, supplier quality, stability programs, and customer complaint investigations.
• Escalate significant quality events to Quality Management promptly.

Jobbeschreibung

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.