Senior Quality Assurance Operations

Job Title: Senior Quality Assurance Operations

Location: Cairo Site, Egypt

Hiring Manager: Quality Assurance Operation Manager

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:

Deviation Investigations:

• All deviations in the process or specifications that can affect product quality are investigated to evaluate the root cause, corrective actions and preventive measures needed to prevent re-occurrence.
• Ensure of non-recurrence of repeated deviations.

• Shopfloor Activities:
  • Review of the batch records before release to the market.
  • Manage batch record archiving
  • Performing quality tours in each manufacturing GMP area.
  • Maintain compliance to local and Sanofi regulations in manufacturing areas.
  • Execution APR plan execution
  • Manage Quality culture program of the site.
  • Monitor Data integrity program of the site.
  • Monitor deviations impacted non-sterile areas.

• Finished goods disposition. -
  • Collecting data daily from the various departments concerned i.e. production, packaging, &     Q.C
  • Checking and reviewing the data to ensure its adherence to specified protocol & therefore, according to Sanofi   Directives & Guidelines & current GMP, on daily basis.  
  • Checking the finished goods retain samples.
  • Following up corrections with the concerned person in the respective department.
  • Summarizing data from protocols through documenting them in standard checklist& batch release.
  • Archiving of batch records with its concerned attachments up to 10 years.          
  • Delegated by QA manager for finished products release/reject activities for non-sterile / sterile batches.

• Quality tours
  • Perform routine Quality tours in the responsible areas.
  • Perform GEMBA & process observation within the responsible areas.

• HSE Responsibilities:
  • Ensures HSE approval on any SOP that requires certain HSE precautions.
  • Ensures HSE approval on any change.
  • Commitment to the appropriate PPE use.
  • Follow the approved HSE policy and requirements.
  • Following the statutory legislation concerning Health, Safety and environmental law.
  • Hydrocarbons/ hazardous substance & waste segregation in accordance with approved waste management system.

JOB-HOLDER’s ENTRY REQUIREMENTS:

• Bachelor’s degree in pharmaceutical science
• 5 -7 years of related experience
• Shop floor activities.
• QA Documentation and compliance systems experience.
• Expert in Pharmaceutical industry & raw materials “API & Non-API”
• Decision making & problem solving.
• Deviation management
• Risk management & Root cause analysis tools.

  competencies:

• Stretch to go beyond the level we have operated at up until now
• Take rapid actions to meet the targeted and planned dates for each task.
• Act in the interest of our patients and customers
• Put the interests of the organization ahead of my own or those of our team.
• Act for Change, strive for results, Cooperate Transversally, Commit to Customer
• Think Strategically, Lead Teams, Develop People, Make Decisions

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