Commercial & Distribution Quality Assurance Lead

Commercial & Distribution Quality Assurance Lead

Quality Assurance / Quality Control Jobs Cairo, Egypt Full Time Applications : 0

Job Description

Quality System:

  • Written procedures must be established and maintained for a quality system at the affiliate level to ensure compliance with applicable regulations and conformance to specified product requirements.

Quality Organization Responsibilities and Authority:

  • Approve or reject all affiliate quality related documents and records to assure that no errors have occurred or, if errors have occurred, that they have been appropriately investigated. The responsibility for product and material release is defined as per local requirement. Legally responsible for release of goods if defined in the Quality/Technical agreement.

Quality Manual & Audit Program:

  • A quality manual must be established and maintained and State how the Abbott Quality System is implemented at the affiliate.

  • A quality audit program must be established and maintained to independently appraise and oversee that the quality systems, including:

  • Audit Readiness.

  • Abbott internal systems - Self inspection.

Complaints Handling:

  • Exceptions, e.g., deviations, nonconformities

  • Product Actions

  • QA Holds

  • Significant events

  • Counterfeiting, Tampering, Diversion and Product Theft

  • Situations Corrective and preventive actions.

Supplier Management

Risk Management

Employee Training

PQR Affiliate Certificate:

  • When affiliate is MAH & required by Reg. agency use appropriate form to certify annual product review

Translation

Change Control

  • A change control process must be established, where required, to evaluate and control Changes, Revalidation/Periodic Review

  • Documentation

  • Labels and artworks

Production Plan Submission & approval process management

Importation plan submission & approval process management

Commercial shipments clearance on CAPA level

Lot Release

Reconciliation of Safety Data-PV

Qualification & Experience:

  • Pharmaceutical degree

  • 3+ years of experience in similar position

  • MS office alert

  • Fluency in English ( written and spoken)

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email Apply to send email to the employer


Email :

corpjat@abbott.com
you can apply through this link :

Apply Link

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Job Summary

  • Date Posted : 5 years ago
  • Job Type : Full Time
  • Location : Cairo, Egypt

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