Duration: Until end of the year
Hours per week: Ad Hoc, some weeks 0 some weeks 40
Start Date: ASAP
Our client is looking for an experienced quality consultant who can help provide quality oversight for their PPQ runs. This resource should help with overseeing and contributing to the compliance strategy for the PPQ while partnering with the validation team for these runs. Work will consist of CMO oversight, batch record review and release, and help out with any deviations/investigations as well as any other quality related events that may arise going from manufacturing to disposition.
Oversight and day-to-day management of outsourced GMP operations at various CMOs to support the successful and compliant execution of GMP operations for Oligomer drug substance, drug product manufacture and label and pack operations to meet regulatory requirements, guidelines, internal policies, and procedures.
Review and approve documentation generated at CMOs, including master batch records, risk assessments, technology transfer, shipping and process validation protocols/reports.
Serve as QA for QC for CoA issuance and Stability reporting.
Final batch disposition of all GMP materials for release into clinical trials encompassing batch record review, change control, deviations, and investigations.
Compile necessary data and analyze metrics for compliance health checks and Quality Management Review.
Represent quality on project teams, as needed and provide GMP compliance. interpretation, consultation, and other supportive services necessary to maintain and improve compliance to ensure product quality, data integrity and patient safety.
Assist in GMP audits, as necessary, and work with internal staff to ensure the implementation of appropriate CAPAs.
QA Ops Oversight (233189) Remote