Manufacturing and Supply
Where the
miracles of
science are made
a reality for patients
Senior Qualification Officer
At a glance
Our teams produce and deliver over 4 billion units of medicines and vaccines every year, ensuring every breakthrough gets to the people who need it most.
Our state-of-the-art facilities, AI-powered smart factories, and cutting-edge automation are redefining what’s possible: ensuring treatments reach patients faster, safer, and more sustainably than ever before. This is where your skills, ambition, and passion can shape the future of healthcare.
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
About the job
KEY RESPONSIBILITIES AND DUTIES:
- Create Calibration Management Program according to Sanofi Guidelines and Directives.
- Perform risk assessment studies for all items or instruments in the plant to define items subjected to calibration.
- Create Calibration Plan and Qualification Plan.
- Calibration of all critical instruments in the site using standard calibrated devices according to calibration management program, sticking to the approved annual plan and/or after Repairs.
- Issuing Calibration Certificates for calibrated items.
- Create IQ, OQ and PQ Protocols for Equipment and Systems in the site and Execute Qualification studies for equipment (Production Machines, Autoclaves, Tunnels, Ovens, Incubators, Refrigerators and Cold Stores… etc.) and HVAC system according to the approved qualification plan and/or after Repairs.
- Establishment of a database for all equipment and machines in the site including manufacturer, model, serial number, and qualification status to evaluate capacity and support CAPEX need in co-operation with maintenance Dept.
- Arrangement and Support Calibration activities performed by third party contractors when needed.
- Supervise Activities executed by contractors and review final reports generated by them.
HSE Responsibilities:
- Ensures HSE approval on any SOP that requires certain HSE precautions.
- Ensures HSE approval on any change.
- Follow the laboratory safety procedures
- 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.
HSE Responsibilities in case joining HSE Excellence team:
- Facilitate and guide the employees to implement the HSE&En. Policies.
- Implement all applicable standards and guides of Sanofi-Aventis in his/her area.
- Ensure from complying with all legal and Sanofi-Aventis requirements.
- Lead his/her team to implement the HSE & EnMS PASS.
- Train his/her team on HSE & EnMS procedures, SOP’s and MSDS.
- Report any accidents/incidents in his/her area to the HSE department.
- Lead his/her team for investigate accidents/incidents to define the root cause.
- Support the area manager for takes the corrective and preventive actions to eliminate reoccurrence of any Environmental or Energy nonconformance.
- Support the area manager for takes the corrective and preventive actions to eliminate reoccurrence of any accident/incident.
- Sharing for HSE / EnMS inspection program, take the corrective actions for any violations in his/her area.
- Lead the team of his/her area for doing full risk assessment and Environmental aspects studies.
- Define and control the required PPE’s for his/her area.
- Define the list of CMR and its operational control for Quality labs and production areas.
- Control the first aid kits in his/her area.
- Leading his/her team for control the significant hazards /aspects and Energy use.
Others:
- Perform other duties as assigned.
- Respect of company’s values, code of ethics and social charter.
- Respect of personal data protection charter.
- Responsible for applying the HSE related requirements for the company in all related working procedures.
JOB-HOLDER’s ENTRY REQUIREMENTS:
- Education:
• Bachelor’s degree in pharmacy, Science or Pharmaceutical engineering.
- Related Experience:
- Years of Experience: +5 years, of related experience
- Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP).
Skills:
- Good command of MS Word. Excel & Power Point
- Good communication & Presentation skills.
- Planning & organizing skills.
- Problem solving skills.
- Report writing skills.
- Ability to co-ordinate several inter-departmental activities.
Pursue Progress. Discover Extraordinary.
Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and 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, gender identity, protected veteran status or other characteristics protected by law.
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Why work with us
- We’re problem-solvers and pioneers. United by the belief that everyone deserves a healthier future. We create best-in-class vaccines that prevent disease and protect lives.
- Innovation drives us. From AI and mRNA to next-gen science, we push the boundaries to deliver first- and best-in-class vaccines for infectious diseases worldwide.
- Growth happens here. With bold investments in R&D and world-class facilities, Sanofians across the entire vaccine lifecycle are shaping the future of global health.
- We do what’s right. Sustainability and DE&I drive our positive global impact—because the diverse communities Sanofians represent are the patients we serve.
All-in on diversity
At Sanofi, diverse perspectives fuel the best solutions for patients. Hear from Monique Vessey, our Supply Chain Transformation Leader, on how her background shapes her approach to delivering life-changing medicines.
"Manufacturing and Supply is the bridge between the science that happens in research laboratories and the people and communities we serve."
Brendan O’Callaghan
Executive Vice President of Manufacturing and Supply
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