Quality Assurance Vacancy At Sanofi Egypt
Risk Management & Inspection Readiness QA Senior
KEY RESPONSIBILITIES AND TASKS:
- 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.
- Follow up implementation of quality risk assessments master plan.
- Act as facilitator for risk assessment process on-site.
- 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.
- 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.
JOB-HOLDER ENTRY REQUIREMENTS:
- 5+ years total experience in Pharmaceutical environment within Quality Assurance/Production.
- Practical experience in risk assessment processes.
- Practical experience for different manufacturing processes regulations.
- Experience in Sterility assurance concepts. “Knowledge of contamination control strategies & Annex 1 requirements is an asset”.
SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS
- 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).