Job Title
Commercial Distribution & Quality Assurance Specialist - OUTSOURCED OPPORTUNITY

About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity
This position works out of our Egypt Affiliate, Cairo in the Established Pharmaceutical Division where we are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.

What You’ll Do:

• Ensure implementation of the below requirements (as applicable):
  Quality System:
  
  • Establish and maintain the written procedures for a quality system at the affiliate level to ensure compliance with applicable regulations and conformance to specified product requirements.
  • Ensure that the affiliate incorporates the system requirements defined in Abbott policies into their quality system.
  Quality Organization Responsibilities and Authority:
  
  • The affiliate CDQA must have the responsibility and authority to 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 quality authority should not be delegated to other function
  Management Review:
  
  • Conduct the Management Reviews quarterly, however Additional Management Reviews can be performed at any time during the year, if necessary.
  Quality Manual
  Establish and maintain A quality manual and State how the Abbott Quality System is implemented at the affiliate.
  Quality Audit Program
  
  • Establish and maintain A quality audit program to independently appraise and oversee that the quality systems, including:
  • Audit Readiness.
  • Abbott internal systems - Self inspection.
  o External suppliers of materials and services
  o Affiliate to notify Region QA by any external audit and to ensure the procedure is implemented
  Complaints Handling:
  
  • Non-medical complaints and medical complaints with potential quality implications including a review of all received non-medical product complaints open/aging status and analysis based on complaint criticality.
• Quality Events Handling:
  Ensure the procedure is implemented and maintained for the following:
  
  • Exceptions, e.g., deviations, nonconformities
  • Product Actions
  • QA Holds
  • Significant events
  • Counterfeiting, Tampering, Diversion and Product Theft
  • Situations Corrective and preventive actions.
  Supplier Management:
  
  • Ensure that the procedure is implemented and maintained.
  Material Control:
  
  • Ensure that the procedure is implemented and maintained.
  Vaccine Procedure:
  
  • Ensure that the procedure is implemented and maintained.
  Risk Management
  
  • Use risk management tools in different parts of the quality system to provide consistent and effective outcomes.
  Employee Training:
  
  • Personnel that perform or oversees GXP (GMP, GCP, GLP) related activities such as approval, investigation, complaint handling, compliance auditing, training, servicing, purchasing and distribution of the product.
  • Maintain related records – Training Curriculum, Training attendance
  Change Control:
  
  • Establish the change control process, where required, to evaluate and control Changes, Revalidation/Periodic Review
  • Document change control
  • Labels and artworks change control
• Reconciliation of Safety Data-PV

Required Qualifications

• Degree in a related field.
  
  • ASQ certification (preferable).
  • 4-5 years of experience working with quality systems and preferable in a similar position.
  • Proficiency in Microsoft Office and quality management systems.
  • Excellent communication, interpersonal, and public speaking skills.
  • Excellent decision-making and problem-solving skills.
  • Strong organizational skills
  • Good command of English language
  • Mobile, open to travel and back up other affiliates within ESL cluster.

Apply Now

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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