Quality Assurance Specialist
Summary
Supports and maintains quality systems at a plasma-derivatives pharma site, ensuring SOPs and cGMP compliance through record and equipment reviews, shipment and incoming supply release, and employee observations. Requires 2+ years in GMP/Quality within pharma, a health-science degree (pharmacy preferred), and English/Arabic proficiency.
Job Objective
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: 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.
Location
Kobry El Kobba