Manufacturing QA, QA
JHL Biotech新竹市Update time: September 14,2019
Job Description
Job Responsibilities
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.
Job Requirements
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.
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.
Job Requirements
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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