Job Summary:

Prepare & conduct regular necessary checks to verify approved production & quality instruction compliance with pre-established criteria.

Duties:

• Follow-up & witness production & packaging activities to ensure compliance & perform necessary checks to ensure product quality.
• Ensure product proper labeling regarding identity & status to maintain product identification
• Fully attend raw material handling steps whether in dispensing or during preparation to ensure material identity, batches & weight.
• Fully attend inspection/packaging start-ups to verify components used, ensure correct batch variables, checks inspection & verification instrumentation / equipment to assure its performance and participate in reconciliation that ensure complete traceability.
• Collect finished, retained, MOH & any additional samples to be delivered to concerned persons for storage and / or analysis.
• Witness process validation & equipment qualification & calibration studies to ensure adherence to EEPI internal SOPs & on time performance according to plan.
• Participate in expired & rejected products disposal committees to ensure product reconciliation & complete destruction.
• Follow-up implementation of target market special requirements during processing & prior to product dispatch including packaging.
• Verify area cleanliness & clearance to assure compliance with GMP standards.
• Plan, execute, report & evaluate for internal audit activities for completeness, participate in assessment of CAPAs & coordinate CAPAs timely implementation with key stake holders.
• Implement recall testing periodically & participate in actual recalls as assigned.
• Issue NCR reports, deviations, NCR(s) risk assessment & review CAPAs to ensure CAPA effectiveness.
• Participate in relevant SOPs & BPR revision.
• Review all BPR records to ensure that data are correct, complete & within company acceptance criteria and accordingly release or hold intermediates for further processing.
• Provide periodical reports with appropriate analysis regarding all compliance functions updates as per superior instruction and work needs to ensure effective & accurate updated records.
• Fulfill other related tasks as asked by management and as arising from the business.