Job 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