Reporting to the QA Drug Substance Group Lead, this role will provide online QA oversight to Drug Substance manufacturing operations. This is a crucial role within
the Quality organization with responsibility for directly supporting the manufacturing operations team on a daily basis, ensuring compliance with cGMP and corporate and
Essential Duties and Responsibilities
- Providing QA support to technology transfer and commercial manufacturing operations.
- Perform QA review of SOPs, risk assessments, change controls and otherdocumentation, as applicable, associated with Drug Substance manufacturing operations
- Ensure that Drug Substance manufacturing operations are conducted according to appropriate behaviors and in compliance with SOPs, batch manufacturing records and other cGMP documentation as applicable.
- Liaise with Manufacturing Operations to ensure that all deviations, investigations and batch manufacturing record reviews are performed, addressed and closed out in a timely manner as defined in SOPs.
- Work with Manufacturing Operations to ensure that all CAPAs, change controls, self-inspection observations, etc. relating to manufacturing operations are addressed and closed out in the required time frame.
- Support internal Quality peers to ensure on-time disposition of drug substance material.
- Provide support for the preparation of regulatory submissions and inspection readiness activities.
- Perform onsite quality monitoring of GMP areas.