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, and support of complex manufacturing investigations, change control, and unexpected result investigations. Required to perform 12-hour shift (rotational night and day, or full night shift as required due to business needs).

• Support the maturation and continuous improvement of quality systems, including On- the-floor quality oversight, deviation management, change control and ensure that the systems are managed in compliance with cGMP expectations
• Participate in on the floor triage and support root cause investigations for major investigation if applicable
• Review and approve minor deviation, change controls, and other quality records such as electronic batch records, SOPs, logbooks, and work orders
• Support in regulatory inspections, and interact directly with regulatory inspectors
• Supporting other QA initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation
• Escalate any significant event to Quality management in a timely manner

As per business shift schedule

• Day Shift: 08:00hrs - 20:00hrs (inclusive of 1-hour lunch break)
• Night Shift: 20:00hrs - 08:00hrs (inclusive of 1-hour lunch break)

Interested candidates may apply through the application system. We regret to inform only Shortlisted candidates will be notified.

EA License No. 01C4394 • RCB No. 200007268E • Derrick Tiew Yong Han EA Registration No. R1877971

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