Analytical QC & AS&T Expert

The Analytical QC & AS&T Expert manages method lifecycle, laboratory performance, and compliance in a pharmaceutical setting. This role ensures the fulfillment of AS&T tasks within the laboratory environment. It focuses on maintaining high standards for analytical processes and regulatory adherence.

Day-to-day responsibilities include developing, validating, verifying, transferring, troubleshooting, and monitoring analytical methods. The expert plans analyses for the QC & AS&T department based on departmental needs and evaluates new technologies and equipment for implementation. Qualifications and leadership follow Novartis and regulatory standards.

Collaboration occurs across departments for resolving extra-laboratory investigations and product submissions to Regulatory Authorities. Compliance with dossiers and pharmacopoeia is guaranteed for all testing methods. Management of deviations, OOS, OOT, OOE, and investigations adheres to internal SOPs.

The role involves putting corrective and preventive actions in place for timely closure and periodically monitoring method performance to propose solutions. It fosters a compliant, efficient laboratory operation. Opportunities arise in leading qualifications and contributing to regulatory expertise.