- Participate in the execution of the Product Disposition activities, including batch production record review, in-process test reivew, in-process material release, and lot release etc.
- Assist QA Management in managing JHL’s deviation, investigation and CAPA systems.
- Assist QA Management in hosting regulatory or due diligence inspections. Oversee the timely response and follow-up to any observations.
- Participate in the daily activities of QA Document Control groups at JHL Biotech, Inc., Taiwan.
- Work as directed to establish and maintain Quality Systems to ensure the manufacture, testing and distribution processes comply with applicable regulatory requirements.
- Participate in the internal auditing program for JHL Taiwan as required.
- BS/MS degree, scientific discpline preferred.
- 2-5 years QA for a regulated industry, pharmaceutical or medical device experience preferred.
- Excellent proficiency in the use of all Microsft Office Applications.
- Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines.
- Ability to effectively participate and communicate on multi-disciplinary teams.
- Knowledge of GMPs and relatd guidelines and regulatory requirements.
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