Lab Quality Assurance Supervisor / October
6th of October City, Egypt Lab Quality Assurance Supervisor / October
About the job Lab Quality Assurance Supervisor / October
Job Objective
To review and assess all procedures, testing methods and reports established in Plasma Testing Laboratory are in compliance to Egyptian regulations, and in accordance to cGMP, following Plasma Testing Specifications established and European Regulation
Key responsibility
- To ensure periodical review of Plasma Testing Laboratory records and logs.
- To initiate investigation for incidents and perform root cause analysis.
- To supervise routine plasma screening tests results.
- To review operations, policies procedures and workflows of the Laboratory.
- To review analytical methods validation protocols and reports.
- To review laboratory procedures and reports.
- To ensure the calibration and maintenance program for the Laboratory equipment is performed as planned.
- To train, supervise and support Quality Assurance specialists to ensure tasks are performed correctly.
- To perform Quality Risk assessment studies and create reports.
To support data retrieval and Epidemiology reports review generated at Plasma Testing Laboratory.
- To participate and support internal and external regulatory inspections and audits performed in the Laboratory.
- To ensure compliance with regulatory authorities.
Academic experience required
- Bachelor's degree in health-related sciences.
- Preferably master's degree or Diploma in Quality assurance.
Professional Experience Required
- Minimum 5 years of experience in certified laboratories.
- Minimum 5 years of experience in a similar position, in environments of Good
--Manufacturing Practices GMP.
- Knowledge in Good Laboratory Practices (GLPs).
Computing Skills
Proficiency in Computers especially excel.
Personal Skills
- Excellent communication skills, verbal & written.
- Agility to learn & study in a fast-paced environment.
- Accuracy and reliability.
- Able to identify problems, root cause, & propose solutions.
Languages
- Fluent English and Arabic language.
