Provide quality oversight during the transfer of analytical methods. Oversee the development, verification, qualification, and validation of analytical methods by reviewing protocols, exceptions, and reports. Ensure adherence to FDA, USP, ICH, and internal regulatory policies for analytical method qualification and validation. Independently coordinate with internal departments and external CMOs/CTLs to facilitate project execution. Apply risk management principles to qualification and remediat
Account
SOFTHQ INC
Greater Boston , Massachusetts
5 days ago
