Associate - Parenteral Drug Product QA
: Job Details :

The PD Drug Product QA Associate collaborates across functions to support the establishment of a new CT DP filling facility. Duties include providing quality support for the production of sterile CT parenteral drug products review as well as support of commissioning and qualification activities for a new manufacturing line or expanded capabilities of existing manufacturing line(s). Additional responsibilities include, but are not limited to:CT Parenteral Drug Product Production:Oversee execution of quality systems to ensure ongoing compliance with regulatory standards and cGMPs. Take part in daily activities and decision-making, including deviations and change controls. Assess the impact of changes and deviations on product and regulatory commitments. Identify opportunities for continuous improvement in productivity and compliance. Review GMP documents, including batch records and logbooks. Qualify in visual inspection and execute related statistical sorting tasks. Advise cross-...Drug, QA, Associate, Product, Support, Manufacturing, Technology