QA Batch Review Specialist

Job title: QA Batch Review Specialist

Location: Cairo Site

Grade: L1

Hiring Manager: Mahmoud Samy - Quality Assurance Operations Manager

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:

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

Pursue Progress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!