Change Control Process Owner

Job Purpose:

The purpose of this position is to manage and oversee the Change Control System within the organization. This role involves receiving and evaluating change control requests, coordinating with various departments to implement pre-action plans, and ensuring compliance with global regulatory requirements. The position aims to facilitate effective communication and follow-up on action plans, ultimately ensuring the successful implementation and closure of change controls. This role is essential for maintaining the integrity and quality of operations through systematic change management

Handling of Change control system

• Receive a change control request form any department
• Follow up of evaluation of change control request.
• Communicate with the experts in concerned departments to perform the impact assessment for their area.
• Follow up the implementation of the action plan with concerned departments
• Evaluation of final report concerning the actions of the change.
• Closing the change control
• Reporting the Change Control status on monthly basis.
• Follow up the implementation of the action plan with concerned departments’ delegates in the Change Control Committee & Follow up Meetings.

Support in PQR preparation for change control chapter

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 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 it’s operational control for Quality labs and production areas.
• Control the first aid kits in his/her area.

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.