QA Specialist (Contract)

Main Responsibilities Responsible for providing oversight for Quality on-the-floor and operations support, the Senior Associate QA will support Facilities & Engineering (F&E), Quality Control, Technology, Process Development, Validation and all non-direct manufacturing across both ASM1 and ASM2. The areas of responsibility include oversight of day-to-day activities, deviations, CAPAs, Change Controls, projects, equipment and systems qualification. The role is a day shift role, but the team may be required to work rotating shift very occasionally (day/night) to support operations or project timelines. Provide Quality oversight to plant operations, ensuring appropriate application and execution of GMP compliance requirements and Amgen Quality Management System in plant operations through phases of commissioning, process qualification, regulatory approval and market supply. Support routine GMP documentation review activities (e.g. SOPs, logbooks, work orders, validation documents, periodic reviews) and ensure key performance indicator met targeted metrics. Support the maturation and continuous improvement of Amgen quality systems, including on-the-floor quality oversight, deviations, change control and CAPA and ensure that the systems are managed in compliance with cGMP expectations. Review and approve deviations, investigations, lab investigations, change controls, and other quality records (with focus on complex records). Participate in root cause investigations for deviations. Support in regulatory inspections and interact directly with regulatory inspectors. Supporting other QA initiatives/activities such as continuous improvement projects, supplier quality, stability program and product quality review. Qualifications Master’s degree OR Bachelor’s degree and 2 years of directly related experience OR Associate degree and/or 6 years of directly related experience OR High school diploma / GED and 8 years of directly related experience. Preferred 3 to 5 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical/biopharmaceutical industry with progressively increasing responsibility and demonstrated experience in quality assurance, and quality systems. Direct experience with bulk manufacturing of biopharmaceuticals/API preferred. Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff. Interested candidates may apply through the application system. We regret to inform only Shortlisted candidates will be notified. By sending us your personal data and curriculum vitae (CV), you are deemed to consent to PERSOL Singapore Pte Ltd and its affiliates to collect, use and disclose your personal data for the purposes set out in the Privacy Policy available at https://www.persolsingapore.com/policies. You acknowledge that you have read, understood, and agree with the Privacy Policy. PERSOL Singapore Pte Ltd • RCB No. 200007268E • EA License No. 01C4394 • EA Registration No. R1877971 (Derrick Tiew Yong Han)