QA Qualification & Calibration Officer

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.
OTHER ACTIVITIES:
* Respect of company values, code of ethics & social charter. Perform other duties as assigned.
HSE ACTIVITIES:
* 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.
JOB-HOLDER's ENTRY REQUIREMENTS
‎1. Education
* Bachelor of Pharmaceutical Sciences, or Science.
‎2. Related Experience
* ‎3 - ‎5 years` experience in related quality assurance function.
* Practical experience in qualification and calibration execution.
‎3. Special Knowledge/Skills
* Communication, Presentation & Computer skills.
* Sense of urgency & follow up skills.
* Time management - High organization & planning skills.
* Good Command of English Language.
* Attention to Details, Hard Worker, and Team Worker
At Sanofi diversity and inclusion is foundational to how we operate and
embedded in our Core Values. We recognize to truly tap into the richness
diversity brings we must lead with inclusion and have a workplace where those
differences can thrive and be leveraged to empower the lives of our
colleagues, patients and customers. We respect and celebrate the diversity of
our people, their backgrounds and experiences and provide equal opportunity
for all.