Process validation: Performing process validation, cleaning validation, and verification
Sampling: Performing routine batch sampling, and sampling of APIs
Documentation: Maintaining records, issuing and controlling standard operating procedures (SOPs), and reviewing analysis records
Line clearance: Performing line clearance activities before starting operations, and providing line clearance at the time of product changes
Monitoring: Monitoring production operations, and monitoring IPQA room clearance
Deviation identification: Identifying, reporting, and documenting unplanned deviations, and performing, supporting, and documenting planned deviations
Compliance: Ensuring compliance with company and medication and drug administration (FDA) guidelines, protocols, and standard operating procedures (SOPS)
Stability program: Supporting the stability program by ensuring all rooms/lines meet requirement