Qualification Professional Officer At Sanofi Egypt
About the job
Controlling, executing, and improving Calibration and Qualification Activities for all critical instruments, equipment, HVAC system and other supporting systems in the site.
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.
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.
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.
Bachelor of Pharmaceutical Sciences
1-3 years’ experience in related quality assurance function.
Sense of urgency
Follow up skills
Time management skills
High organization & planning skills
Good Command of English Language
Attention to Details
Stretch to go beyond the level we have operated at up until now.
Take actions instead of waiting to be told what to do
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