QA Production Associate
Responsibilities:
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Support the maturation and continuous improvement of site quality systems, including On-the-floor quality oversight, deviation management, change control and ensure that the systems are managed in compliance with cGMP expectations
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Participate in on the floor triage and support root cause investigations for major investigation if applicable
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Review and approve minor deviation, change controls, and other quality records such as electronic batch records, SOPs, logbooks and work orders
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Support in regulatory inspections, and interact directly with regulatory inspectors
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Supporting other QA initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation
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Escalate any significant event to Quality management in a timely manner
About You:
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Bachelor’s Degree in Science or engineering related
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1-4 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. Fresh graduates are welcome to apply.
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Direct experience with bulk manufacturing of biopharmaceuticals preferred.
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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
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Fluency in written and spoken English
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Based in Tuas, able to work predominantly on night shift, 8pm to 8am, on a 2-2-3 shift pattern