Senior Quality Associate

Job description

The Sr. Quality Associate is responsible for m anaging deviations, investigations, CAPAs, product technical complaints and change controls associated with development activities and manufacture of Investigational Medicinal Product within CSL Clinical development portfolio. To do this the GMP Sr. quality associate will has the primary purposes of ensuring compliance with GMP/GSP/GxP by providing front like quality guidance and support across all phases of Technical Product Development. You will also e nsure self-inspections are conducted and followed up in a timely manner and provide quality and compliance support throughout all aspects of technical product. This role reports to: Regional Product Development Quality Lead (APAC/EU) Positions reporting into this role: This role has no direct reports Main Responsibilities and Accountabilities: - Participate in IPT Project and associate delivery team meetings, provide quality/compliance leadership, guidance and advice. - Manage deviations and OOS investigations and facilitate/attend Deviation Review Board meetings as required. - Manage and facilitate the deviation meeting process, manage deviations to closure, including significant and...