Center Quality Assurance Specialist ( Tal Elkbeer)
Grifols Egypt for Plasma Derivatives · Ismailia, Egypt ·
- Category
- QA
The Quality Assurance Specialist maintains quality systems and ensures compliance with SOPs and cGMP regulations at a plasma center. Key tasks include reviewing records, performing equipment quality control, inspecting incoming supplies, and conducting employee observations using MS Office.
Job Objective:
One sentence summary of the main objective of the job, the most important activities and the means and guidelines to obtain the objectives.
The Quality Assurance (QA) Specialist is responsible for supporting and maintaining quality systems to ensure products and processes comply with internal procedures as well as local and international regulatory requirements.
Environment Internal and external interactions i.e.: with other departments/divisions, international scope, providers, customers)
Internal: Center Management, DC staff, Internal auditors, Corporate Quality and Managers.
External:Donors, Health authorities inspectors.
Key responsibility:
- Ensure SOPs and cGMP regulations are followed.
- To perform periodical review of DCGMP related records.
- To perform periodical equipment quality control review.
- To perform periodical review of equipment incident logs.
- To verify and release sample shipments.
- To inspect and release incoming supplies.
- To perform periodical employee observations.
Academic experience required:
- Bachelor's degree in health-related Sciences. Preferably in Pharmacy.
- Knowledge in Quality Management.
- Strong integrity and commitment to quality and compliance.
- Professional Experience Required
- At least 2 years of experience in Good Manufacturing Practices (GMP) environments in Quality
- Area within Pharma industry.
Computing Skills:
Ms Office knowledge.
Personal Skills:
- Ability to understand, explain, follow and enforce SOPs, protocols and other regulatory guidelines.
- Accuracy and reliability.
- Can work independently, excellent organizational skills, and attention to detail.
- Performs a high-level document review.
- Ability to work with cross functional areas.
- Good ability to identify problems and propose solutions.
Languages:
Intermediate level of written and spoken English
Fluent in Arabic.