Risk Management and Inspection Readiness QA Professional

Job title: Risk Management and Inspection Readiness QA Professional

Location: Cairo Site

Grade: L1

Hiring Manager: Mostafa El Naggar

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:

• Quality Risk process.
• GQD compliance follow up.
• Sterile Annex-1 compliance.
• Self-inspections participation.
• Contamination Control strategy implementation.
• Quality maturity index tool management.
• Inspection Readiness.

KEY RESPONSIBILITIES AND DUTIES:

• Contamination Control Strategy (For Sterile):
  • Act as the Contamination Control Subject Matter expert for the site.
  • Lead and follow Annex 1 project, manage the project implementation plan with different cross functional teams in IA.
  • Contamination control strategy leading and ensure its implementation on-site.
  • Maintain the Holistic contamination control strategy up-to-date for sterile facility.
  • Perform the responsibilities of the contamination control SME.
• Quality Risk Management
  • Execution of quality risk process.
  • Act as facilitator for risk assessment process on-site.
  • Ensure site risk profile is updated and mitigation actions are in place.
• Global Quality Documents Gap analysis
  • Following up the performance of gap analysis for any updated global quality documents and implementation of any raised actions from this gap analysis
  • Perform gap analysis for the assigned documents.
  • GOPs direct implementation.

• Annex 1 Compliance:
  • Supervising and participation in Annex 1 required gap assessments.
  • Performing of required risk assessments.
  • Creation of Holistic contamination control strategy.

• Participate in Site Self inspection for GMP related areas among all industrial affairs departments
  • Preparation of an annual plan for internal audit for different departments on yearly basis.
  • Participate in Execution of the plan through conducting self-inspection in different departments.
  • Creation of self-inspection report within the specified timelines.
  • Follow up the creation of the required action plans by the concerned area responsible within the specified timelines.
• Inspection Readiness (GRIC, SQRs, Inspections and Audits Management).
  • Ensure inspection readiness according to the IR Sanofi handbook.
  • Create satisfactory action plan for the communicated GRIC memos, SQR reports, and received audits or inspections by the concerned area responsible.
• Suppliers and subcontractors’ Audits
  • Set the annual audit plan for Cairo site.
  • Manage the implementation of the plan and follow it’s closure.
  • Participate in Suppliers and subcontractors’ audits.
  • Documentation of audit reports and follow up of its relevant action plans implementation.

• Respect of company values, code of ethics & social charter.

• Perform other duties as assigned.
• 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.

JOB-HOLDER’s ENTRY REQUIREMENTS:

Education:

• Bachelor of Pharmaceutical Sciences

Related Experience:

• 0-2 Years of Experience

Special Knowledge/Skills:

• Good communication & Presentation skills.
• Planning & organizing skills.
• Problem solving skills.
• Report writing skills.
• Ability to co-ordinate several inter-departmental activities.
• Good command of MS Word, Excel & Power Point.
• Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP).

Pursue Progress. 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.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!