Lookback Alert Supervisor

Job Objective

Responsible for ensuring that the lookback system is adequately managed through adherence to reference guidance and Grifols policies, supervision of Lookback Alert staff ensuring active communication with plasma donor centers, good control of information system data, and removal processing inside the PLC. Ensure process compliance for reporting lookbacks to the Consignee.

Environment

Internal: PLC Operations, PLC Quality, Donor Centers and Corporate Quality.

External: Auditors, Consignee Quality and Lookback Team and Corporate IT Team.

Key responsibility

Ensure that the process of lookback receival is consistently applied per current policies and regulations in place.

Ensure information system data integration and compliance with Lookback and PDI policy.

Participate in lookback practice gap analysis and actively support process development.

Identify lookback system improvement opportunities.

Establish and sustain proper communication with the Consignee to ensure that information support is provided in a timely manner.

Train current and new employees, and maintain Lookback staff training program documents.

Supervise the activities of the Lookback staff including performance management, disciplinary action, and professional development.

Support Quality Assurance functions in the PLC, as needed, through cross-functioning tasks.

Ensure compliance with Quality guidelines and Regulatory authorities.

Academic experience required

Bachelors Degree in Science or Health-related Sciences, preferably Pharmacy.

Knowledge in Quality Management desired.

Professional Experience Required

Minimum 5 years of experience in a similar position, in environments of Good Manufacturing

Practices GMP. Pharmaceutical background.

Computing Skills

Proficiency with computers.

Familiarity with SAP and Plasma Logistics computer systems and software applications.

Personal Skills

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 and protocols.

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

Languages

Excellent written and spoken English and Arabic.