• Collaborate with the Lab unit to ensure compliance of test methods within regulations.
• Support investigations associated with OOS and OOT tests results
• Lead or participate in Lab tours for continuous improvement of GMP and GDP practices
• Utilizes industry and process excellence standards in routine quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
• Supports product and process deviations, including Risk assessments, root cause investigations and preventive / corrective actions.
• Support on site audits and Prepare the Lab for audits.
• Leading or participating in continuous improvement projects to implement change within Operations.
• Review and approval of QC procedures, documents, protocols, reports and CC.