QA Qualification professional

Job title: QA Qualification Professional

Location: Cairo Site

Hiring Manager: Validation and Qualification Section Head

About the job
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Job Purpose:

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.

PursueProgress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s 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, or gender identity.

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