Center Quality Specialist
- Grifols Egypt for Plasma Derivatives
- Banhā, Egypt
- EGP 180,000 – EGP 300,000
KEY RESPONSIBILITIES :
- Development, review, revision and implementation of SOPs as required.
- Manage and evaluate (trending) complaints, deviations, Corrective Actions and Preventative Actions (CAPAs), and Change Control requested.
- Develop a system of control through main Quality KPIs.
- Assist Regulatory projects that involve QA oversight.
- Annual Quality reviews for compliance with Egyptian registration and licenses approved by Health Competent Authorities.
- Monitor QA aspects of Plasma Collection, warehousing, Testing and shipping practices for compliance with Egyptian Regulation and with Product licenses approved.
- Liaise with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations
ACADEMIC EXPERIENCE REQUIRED :
- Bachelor s Degree in Health-related Sciences.
- Post-Graduate Certification in Quality Management.
- Knowledge of cGMP requirements preferred
PROFESSIONL EXPERIENCE REQUIRED :
- Typically requires a minimum of 3 years of related experience. Blood banks or Pharma background
preferred.
Skills
- SOP Development
- CAPA Management
- Quality KPIs
- cGMP compliance
- Regulatory Affairs
- Audit Management
- Complaint Investigation
