Our Pharma client is currently searching for a Quality Operations Specialist with expertise in both development and commercialization of products.

The primary responsibility of this position will be to ensure quality oversight of assigned projects/CMO’s for the clinical/commercial product manufactured and to work cross-functionally providing updates and meeting complex timelines for mission critical deliverables.

Qualified applicants will have the following skill sets:

B.S. degree in Life sciences, chemistry or equivalent.
5+ years of GMP Quality experience with focus on cGMP compliance and product quality for US and EU. Drug Substance.
Experience with using risk-based principles and decision making to ensure compliance at all stages of development.
5+ years of experience with relevant US, EU and ICH requirements.

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GMP Quality Operations Specialist

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