Laboratory Quality Assurance Specialist at GRIFOLS, S.A.

6th of October City, Giza, Egypt -

Full Time

Start Date

Immediate

Expiry Date

13 Jun, 26

Salary

0.0

Posted On

15 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Quality Control, Validation Testing, Good Documentation Practice, cGMP Requirements, Regulatory Compliance, Data Interpretation, SOP Generation, Epidemiological Data Review, Time Management, Analytical Skills, Communication Skills, Organizational Skills, Planning Skills

Industry

Pharmaceutical Manufacturing

Description

Job Objective: To assess performance of testing methods established in plasma testing laboratory making a follow up of Quality Control assessment of the results. To ensure that all methods are in correct validation status and participate in Proficiency testing studies. To review test results obtained in plasma Testing Laboratory. Environment: Internal: Laboratory Operations and Quality Manager, Epidemiology Specialist, Plasma Quality Assurance, and Grifols Egypt for Plasma Derivatives plasma general management. External: Third-party providers. Key responsibility To perform periodical review of Plasma Testing Laboratory records and ensure Good Documentation Practice (GDP) is followed. To perform periodical equipment Quality Control review. To perform periodical review of equipment incident logs. Supervises operations, policies and procedures, workflow and activities of the laboratory. Participate in generating and reviewing SOPs in Plasma Testing Laboratory. Review Validation Testing methods in order to comply with cGMP requirements according to Egyptian regulation, as well as in accordance to FDA and European requirements. Evaluate Quality Control programs established in Plasma Testing Laboratory. Participate in Proficiency testing supporting Plasma Quality Control Manager, through Test results revision and evaluation. Review Epidemiological data. Ensures compliance with all regulatory agencies. To support Plasma Quality Control Testing Laboratory Manager of data retrieving process related to testing laboratory. Academic experience required: Bachelor s Degree in Health-related Sciences, Pharmacist preferable. Knowledge of Quality Control performance and Quality Assurance preferred. Knowledge of cGMP requirements preferred. Professional Experience Required: Typically requires a minimum of 2 years of related experience in a similar position, in environments of Good Manufacturing Practices GMP in Pharmaceutical industry. Computing Skills Proficiency in Computers and Microsoft applications. Personal Skills: Organized and able to manage time effectively. Ability to work within a highly regulated, labor intensive environment. Analytical and enquiring mind with the ability to interpret data and facts. Excellent oral and written communication skills to produce clear and concise factual findings and ability to present effectively to groups. Effective organizational and planning skills with ability to meeting deadlines required. Languages: Written and spoken English and Arabic.

Responsibilities

The specialist assesses the performance of testing methods in the plasma testing laboratory, ensuring all methods are correctly validated and participating in proficiency testing studies. Key duties include periodically reviewing laboratory records, equipment logs, and test results to ensure compliance with Good Documentation Practice and regulatory standards.