Senior Quality Assurance Inspector at GRIFOLS, S.A.

6th of October City, Giza, Egypt -

Full Time

Start Date

Immediate

Expiry Date

26 Sep, 26

Salary

0.0

Posted On

28 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, PLC Operations, Deviation Reporting, CAPA Evaluation, Regulatory Compliance, Risk Mitigation, Documentation Review, Auditing, Quality Management Systems, Plasma Logistics, Traceability Verification, Customer Feedback Investigation

Industry

Pharmaceutical Manufacturing

Description

Job Objective: Quality Assurance (QA) Senior Inspectors work with PLC Operations during the production process, by ensuring appropriate process of raw materials receiving from DCs, documentations approval from starting material until the final Plasma Lot shipment for distribution and sales at the Grifols Plasma Logistics Center (GPLC). QA Senior Inspectors oversights and verify on deviations reporting, investigation and timely close out of investigations associated with Plasma and related processes in the PLC. QA Senior Inspector coordinates and investigates Customer feedback related to shipped Plasma lot to ensure product quality are meet as pre-determined GEPD Quality standards. Key responsibility Oversee and ensure timely approved incoming plasma shipment documentation and in-process plasma batches (PU's) by confirming specifications, rejects and returns unacceptable materials as directed by Quality system in place. Review final plasma lots by confirming customer and regulatory specifications and communicating required adjustments to Plasma Release Manager. Ensure that the quality of the production operation is in compliance with customer specifications and GPLC standard operating procedures. taking in consideration auditing consultancy and concerns raised from external parties. Ensures that deviations are tracked, well assessed, and risk on Plasma product is mitigated as well as trends actions needed in response to these non-conformances including those CAPA evaluation. Quality Action plans follow up and effectiveness confirmation to meet the required results as per GEPD QMS. Review standard operating procedures related to Source Plasma and quality systems at Plasma Warehouse level. to ensure standard operating procedure related to Source Plasma and quality systems at Plasma Warehouse level meet GEPD quality standards and specifications. Ensure Final Plasma Lot shipping activities is conforming to pre-determined quality of distribution preparation by verifying shipping data traceability. Participate actively in addressing Quality risks related to Plasma logistics Center and support Plasma operations in planning for risks mitigation. Support Lookback function when needed by provide plasma shipments/lots required data in order to optimize lookback processes throughout different operations stages. Academic experience required Bachelors Degree in Health-related Sciences. Knowledge in quality Management. Strong integrity and commitment to quality and compliance. Professional Experience Required Typically requires a minimum of 4 years of related experience; preferred Pharma background. Very Good English

Responsibilities

Oversee the quality assurance process for raw materials and final plasma lot shipments to ensure compliance with regulatory and company standards. Manage deviation reporting, investigations, and CAPA evaluations to mitigate risks within the plasma logistics center.