QA Qualification and Calibration Officer At Sanofi Egypt
Sanofi S.A. is a French multinational pharmaceutical and healthcare company headquartered in Paris, France.
Sanofi engages in the research and development, manufacturing and marketing of pharmaceutical drugs principally in the prescription market, but the firm also develops over-the-counter medication. The corporation covers seven major therapeutic areas: cardiovascular, central nervous system, diabetes, internal medicine, oncology, thrombosis and vaccines .
About QA Qualification and Calibration Officer Position :
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.
Respect of company values, code of ethics & social charter. Perform other duties as assigned.
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.
Requirements For QA Qualification and Calibration Officer Position :
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