Manager, QCA

Scope of Function: Manages, supervises, and oversees the Quality Control Analytical team with solid technical and scientific experience in the pharmaceutical industry to ensure adherence to established quality standards. Manage Qualification and Validation of Analytical Methods transferred by Protein Characterization Group. Overall responsibility for the Quality Control Analytical functions. Responsible for planning and successful execution of QC testing and tasks. Participate in Internal and external audits and inspections. Ensure compliance with regulatory and corporate requirements. Lead the Investigations for OOS/ABT/OOT. Propose corrective actions to improve compliance with quality specifications.