Operational release activities include leading deviation investigations and trend investigations alongside documentation of the root cause analysis, identification of appropriate Corrective and Preventive Actions (CAPAs) and product impact assessment that supports timely lot disposition.
Degree in Biotechnology/Biomedical Science
Relevant manufacturing/process/QA operation experience would be advantageous
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* Perform detailed Root Cause Analysis (RCA) using methodologies such as 5 Whys, Fishbone/Ishikawa, FMECA, causal/event analysis and fault-tree analysis.
* Assess product/batch impact and quality impact arising from manufacturing deviations and determine appropriate investigation outcomes.
* Develop and implement appropriate CAPAs, including effectiveness checks, to prevent recurrence.
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Troubleshoot and identify root causes of electrical faults
Prepare and submit check sheets for plant rooms and monthly summary reports on installation conditions
Supervise operation of mechanical and electrical systems, including standby generators and air-conditioning systems, in compliance with relevant authority requirements
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