QA Batch Review Specialist

JOB PURPOSE:

QA operation department plays a vital role in establishment and maintenance of quality system in Sanofi Cairo site to ensure delivery of high-quality products that comply with global quality standards and regulatory requirements.

Job Responsibilities:                      

• Shopfloor Activities:
  • Review of the batch record received in the sterile area before release.
  • Maintain compliance to local and Sanofi regulations in manufacturing areas.
  • Prepare assigned PQRs.
  • Retain sample review.
  • Implement the assigned CAPAs and ERs.
  • Review and report the status of the quality stock at the QA level.
  • Review the assigned documentation as assigned on Qualipso system.
  • Update and conduct the shopfloor +QDCI meeting as assigned.
  • To follow GMP compliance for activities done in Utilities (HVAC & Water stations) by conducting periodic tours in these areas.
• Quality tours:
  • Conduct Quality tours & process observation within assigned area.
• Participate in Site Self inspection for GXP related areas among all M&S departments:
  • Preparation of an annual plan for internal audit for different departments on yearly basis.
  • Participate in Execution of the plan through conducting self-inspection in different departments.
  • Creation of self-inspection report within the specified timelines.
  • Follow up the creation of the required action plans by the concerned area responsible within the specified timelines.
• Participation in Investigations of Site Deviations:
  • Conduct investigation assigned impacting product quality are investigated to evaluate the root cause, corrective actions and preventive measures needed to prevent re-occurrence.
• 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.

• JOB-HOLDER’s ENTRY REQUIREMENTS:
• Education:Bachelor’s degree in pharmaceutical science
• Related Experience:
• Working in the pharmaceutical industry (2 - 4 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