QA Operational Support Specialist

Job title: QA Operational Support Specialist

Location: Cairo Site

About the job
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

JOB PURPOSE:

• Maintain and manage the QA product shopfloor to ensure quality is built into the product. This guarantees the conformance of the final product with its predetermined specifications and compliance with GMP regulations, Sanofi industrial quality and compliance directives and guidelines, and local and national requirements.

KEY RESPONSIBILITIES AND DUTIES:

• Participation in Investigations of Site Deviations:
  • Conduct investigations assigned impacting product quality are investigated to evaluate the root cause, corrective actions, and preventive measures needed to prevent re-occurrence.
  • Conduct LI-related investigation assigned to product quality to evaluate the root cause, corrective actions, and preventive measures needed to prevent re-occurrence.
• Shopfloor Activities:
  • Review the batch record received in the assigned area of responsibility before release.
  • Maintain compliance with local and Sanofi regulations in manufacturing areas.
  • Implement the assigned CAPAs and Effectiveness Checks.
  • Implement the assigned Change actions.
  • Review and report the status of the quality stock at the QA level.
  • Review the documentation assigned to the QualiPSO system.
  • Attend & conduct the shopfloor meetings as assigned.
• Quality tours
  • Conduct Quality tours & process observation within assigned areas.
• HSE Responsibilities:
  • Commitment to the appropriate PPE use.
  • Follow the approved HSE policy and requirements.
  • Following the statutory legislation concerning Health, Safety, and environmental law.
• Others:
  • Respect for the company’s values, code of ethics, and social charter.
  • Show and apply the TRT & PTW principles.
  • Respect for personal data protection charter.

JOB-HOLDER’s ENTRY REQUIREMENTS:

• Education:

  Bachelor’s degree in pharmaceutical science

• Related Experience:

• Working in the pharmaceutical industry (3 – 5 years) in:
• QA, Shop Floor, IPC.
• QA, Compliance.
• Experience is preferably in a solid DF area.
• Special Knowledge/Skills:
• Shop floor activities.
• QA Documentation and compliance systems experience.
• Background knowledge in the pharmaceutical industry
• Decision making & problem solving.
• Risk management & Root cause analysis tools.

Play To win Behaviors:

• Stretch to go beyond the level we have operated at up until now.
• Take actions instead of waiting to be told what to do.
• Act in the interest of our patients and customers
• Put the interests of the organization ahead of my own or those of our team