Quality Assurance Professional Shop floor At Sanofi Egypt
KEY RESPONSIBILITIES AND DUTIES:
All deviations in the process or specifications that can affect product quality are investigated to evaluate the root cause, corrective actions and preventive measures needed to prevent re-occurrence.
Ensure of non-recurrence of repeated deviations.
Review of the batch records before release to the market.
Manage batch record archiving
Performing quality tours in each manufacturing GMP area.
Maintain compliance to local and Sanofi regulations in manufacturing areas.
Execution APR plan execution
Manage Quality culture program of the site.
Monitor Data integrity program of the site.
Monitor deviations impacted non-sterile areas.
Perform routine Quality tours in the responsible areas.
Perform GEMBA & process observation within the responsible areas.
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.
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:
Bachelor’s degree in pharmaceutical science
0 - 3 years of related experience
Shop floor activities.
QA Documentation and compliance systems experience.
Expert in Pharmaceutical industry & raw materials “API & Non-API”
Decision making & problem solving.
Risk management & Root cause analysis tools.
Stretch to go beyond the level we have operated at up until now
Take rapid actions to meet the targeted and planned dates for each task.
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