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Quality assurance laboratory manager

Sant Cugat del Vallès
Grifols
De 30 € a 50 € por hora
Publicada el 13 junio
Descripción

Mission

Si le interesa solicitar este empleo, por favor, asegúrese de cumplir los siguientes requisitos que se enumeran a continuación.

To review and ensure that all procedures, testing methods and reports established in GEPD Plasma Testing Laboratories are in compliance to Egyptian regulations, and in accordance to cGMP, following Plasma Testing Specifications established and European Regulation. To manage and supervise Plasma Testing Laboratories Quality projects. To propose continuous improvement measures related to the quality systems of the Laboratories. To supervise the Quality Risk Management (QRM) process for the Laboratories.

What your responsibilities will be

- To review and ensure that all procedures established are in accordance to cGMP.

- To supervise GEPD Plasma Testing Laboratories quality system and quality culture.

- To ensure investigation for incidents are initiated, as well as root cause analysis are properly in place.

- To participate and support internal and external regulatory inspections and audits performed in the Laboratories.

- To manage and supervise Plasma Testing Laboratories Quality projects.

- Actively participate in Laboratory meetings for the follow-up of activities related to open Change Controls.

- Coordinate the tasks required to be developed within the different areas of the company.

- Review new procedures and processes to be implemented in the Laboratory under the scope of the Change Controls open.

- To ensure continuous improvement measures related to the quality systems of the Laboratories.

- To supervise the monitoring of corrective and/or preventive actions implemented within the Laboratories. Ensure their proper implementation and effectiveness.

- To monitor quality system indicators.

- To propose improvements in the Laboratory's processes to enhance the quality system.

- To supervise the Quality Risk Management (QRM) process for the Laboratories.

- To supervise Quality Risk assessment studies and reports, as well as coordinate mitigation tasks

Who you are

- Bachelor’s Degree in Life Sciences (Biology, Pharmacy, Biotechnology or related fields)

- Minimum 3-5 years of experience in a related field.

- 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.

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

- Advanced level of Spanish and English.

- Comfortable with frequent travel as the role requires a high level of mobility.

Benefits package

Flexibility for U Program: Occasionally Remote.

Contract of Employment: Permanent position.

We believe in diverse talent and want to remove any barriers that may hinder your participation. xpzdshu

Grifols is an equal opportunity employer.

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