Compliance Specialist - QAPosted 2 months ago
158Applicants for2 open positions
- 0In Consideration
- 0Not Selected
Skills And Tools:
Prepare & conduct regular necessary checks to verify approved production & quality instruction compliance with pre-established criteria.
- 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.
- Bachelor degree of Science.
- Experience from 1 : 3 years in related function.
- Excellent Communication & Organization Skills .
- Alexandria City residents or nearby are preferred.
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