• Collaborate with "One Lab" unit to ensure compliance of test methods within regulations.
• Support "One Lab "investigations associated with OOS and OOT tests results
• Leads or participating to "One 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 .Prepare the "one 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.
Reported to :
• QA for QC employee reports to Labs Q&C Lead