Quality Assurance Supervisor

18 hours ago

th of October City, Giza, Egypt Grifols Egypt for Plasma Derivatives Full time

Verifies critical systems at Plasma Logistics Center (PLC) and documentation associated with the destruction of plasma. Ensures compliance to approved procedures. This position has responsibility for the supervision of the daily activities of the PLC Quality Assurance staff.

Environment

Internal: Manufacturing, Quality, Donor Centers, Plasma Warehouse, Plasma Testing Laboratory, Manufacturing Facility, Administration and Services Divisions, and Grifols Egypt for Plasma Derivatives plasma general management.

External: Heal authorities, government agencies, and auditors.

Key responsibility

To register the Quality process as per established procedures in the electronic material management system.

To document deviations observed during the process of Quality inspection process according to GEPD company policy, and to inform stakeholders, as required.

To ensure that all tasks are performed in a timely manner.

Supervises the daily activities of the PLC Quality Assurance staff and ensures that required activities related to the receipt, storage, clearing, processing of lookback alerts, quarantine of unsuitable units, and release of source plasma for further manufacturing.

Reviews and verifies temperature documentation to ensure conformance to appropriate temperature specifications.

Investigates and documents deviations noted as a result of routine compliance reviews, internal and external audits and customer complaints.

Investigates and documents deviations noted as a result of routine compliance

Monitors the PLC to maintain compliance with all applicable regulations.

Trains current and new employees maintains and updates training records of the QA staff.

Supervises the activities of quality assurance staff including hiring, performance management, disciplinary action and professional development.

Academic experience required

Bachelor's degree in health-related Sciences.

Knowledge of cGMP required.

Professional experience required

Prefer 2 years of experience in a similar position working in a Good Manufacturing Practice (GMP)-regulated environment.

Pharmaceutical background preferred.

Computing skills

MS Office Proficiency.

Organized and able to manage time effectively.

Ability to work within a highly regulated, labor intensive environment.

Ability to understand, explain, follow, and enforce SOPs.

Ability to plan, communicate and execute activities for the improvement of overall operations.

Strong integrity and commitment to Quality and Compliance.

Ability to work in groups and with other departments.

Excellent oral and written communication skills to produce clear and concise factual findings.

Ability to analyze and interpret data, identify problems, and propose solutions.

Effective organizational and planning skills with ability to meeting deadlines required.

Proactive and results-oriented with a strong attention to detail.

Languages
Excellent written and spoken English and Arabic.

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