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QA / RA Compliance Specialist
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- A minimum of 3 years related experience in the pharmaceutical manufacturing industry.
- Strong background working with Change Controls and management of change control processes.
- II. Basic Function: This position is responsible for quality and regulatory affairs services, including but not limited to, Drug Master File (DMF) Updates, Health Authority GMP requests, processing and investigating customer product complaints; preparing annual product reviews, tracking and trending, and follow-up of the Change Control and CAPA programs
- This position interacts directly with manufacturing, engineering, product development, technical services, validation, etc.
- personnel and is responsible for the quality/regulatory feedback loop to those impacted areas.
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