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Compliance Specialist - QA

European Egyptian Pharma...
Ameria, Alexandria

Compliance Specialist - QA

Ameria, AlexandriaPosted 2 months ago
158Applicants for2 open positions
  • 6Viewed
  • 0In Consideration
  • 0Not Selected

Job Details

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Job Description

Job Summary:

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.

Job Requirements

  • 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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