QA Specialist

Sanofi

MAIN MISSIONS

• Ensure the implementation and monitoring of actions defined within their area of ​​responsibility in order to guarantee the proper functioning of the CERB
• Ensure regular tours at the gemba level and participate in the site self-inspection program by ensuring the conduct, reporting and follow-up of the implementation of actions.
• Preparation of batch files for manufacturing, packaging and printing of labels.
• Ensure quality review of batch files manufactured (or packaged) at the Sidi Abdellah site with a view to their release:
  Manufacturing batch file, Packaging batch file, Analytical batch file.
• Managing ongoing diversions:
  Identifying the diversion, initiating the investigation, monitoring the investigation in collaboration with the various departments involved, proposing corrective and preventive actions, and conducting effectiveness reviews.
• Conducting periodic trend analyses: trending deviations
• Participate in the periodic training of staff at the Sidi Abdellah site and in the resulting recordings.
• Prepare, within the given timeframe, the Annual Review of Products manufactured or packaged on site. Analyze it and propose improvement plans.
• Participate in the drafting of site quality procedures in accordance with the group's directives, standards and guides.
• To participate in the continuous improvement process by carrying out field visits, process confirmation and by participating in the various projects.
• Contribute to the establishment of a quality culture at the Sidi Abdallah site by leading or supporting the various initiatives.
• Respect and enforce Sanofi's Quality and HSE policies within the site.

REQUIRED SKILLS

• Advanced knowledge of Quality systems and good manufacturing practices.
• Advanced knowledge of pharmaceutical production processes.
• Mastery of investigation methods
• Knowledge of quality risk assessment methodologies.
• Knowledge of continuous improvement systems.
• Good knowledge of data analysis and statistics.
• Sense of organization and prioritization.
• Analytical and synthesis skills.
• Developed interpersonal skills and good communication.
• English level: Intermediate.
• Education / Professional Experience
• Minimum diploma m Bac+4/Bac+5 in pharmacy, process engineering or equivalent.
• A minimum of 2 years of proven experience in a similar position in the pharmaceutical industry.