Quality Assurance Professional Shop floor At Sanofi Egypt
.jpg "Quality Assurance Professional Shop floor At Sanofi Egypt")
Quality Assurance Professional At Sanofi
Job Purpose:
Support during the project of the installation of new ampoule line. (project duration until end of 2024)
Key Responsibilities:
Deviation Investigations:Investigate different types of events related to different production activities
Ensure of non-recurrence of repeated deviations.
Shopfloor Activities:
Review of the batch records before release to the market.
Manage batch record archiving
Maintain compliance to local and Sanofi regulations in manufacturing areas.
Execution PQR plan execution
Monitor deviations impacted non-sterile areas.
Collecting data daily from the various departments concerned i.e. production, packaging, & Q.C
Checking and reviewing the data to ensure its adherence to specified protocol & therefore, according to Sanofi Directives & Guidelines & current GMP, on daily basis.
Checking the finished goods retain samples.
Following up corrections with the concerned person in the respective department.
Summarizing data from protocols through documenting them in standard checklist
Perform routine Quality tours in the responsible areas.
Perform GEMBA & process observation within the responsible areas
HSE Responsibilities:
Ensures HSE approval on any SOP that requires certain HSE precautions.
Ensures HSE approval on any change.
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 it’s 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.
JOB-HOLDER’s ENTRY REQUIREMENTS:
Education:
Bachelor’s degree in pharmaceutical science
Related Experience:
0 - 2 years of related experience
Special Knowledge/Skills:
Shop floor activities.
QA Documentation and compliance systems experience.
Decision making & problem solving.
Deviation management
Risk management & Root cause analysis tools.