QA Compliance Specialist At Pharco B international
Summary:
Conduct necessary checks to verify approved production & quality instruction compliance with pre-established criteria.
Job requirements:
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 identity.
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 PBI 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.
Qualifications:
B.Sc. degree in Science with relevant experience.
Years of Experience: 1
Available Vacancies: 6
Job Level: Specialist
Function: QA - Compliance
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