Senior Qualification Officer

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.