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avatar for Danielle Metzger

Danielle Metzger

Kinapse
Manager, Development Operations, Q&C
Accomplished Quality Professional with a broad background in Pharmaceutical life sciences having R&D and commercial (sterile/non-sterile) experience with over 20 years practice. Specialize in Deviation/CAPA Management and TrackWise systems. Well versed in cGMP knowledge, FDA/EU regulations and guidelines. Other areas of expertise include: SOP Development with use of accelerators and advanced mapping skills, Product Complaint investigations, APR/PQR compilation and reporting, batch record/documentation revision and issuance, batch record review/product release, client and agency audits and quality training.