Quality Assurance Laboratory Manager

Grifols Sa; Málaga; Híbrido; EUR 65.000 - 95.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Occasional remote work

Equal opportunity employer

Descripción de la vacante

Grifols seeks a qualified QA leader to review and ensure that all procedures align with cGMP in Plasma Testing Laboratories. The role will supervise quality systems, drive investigations and root cause analyses, and support regulatory inspections and audits.

You will manage quality projects, coordinate Change Controls, and monitor CAPA and QRM activities across the labs, with a strong emphasis on compliance and process improvement.

Formación

• Bachelor’s Degree in Life Sciences (Biology, Pharmacy, Biotechnology or related fields).
• 3–5 years of experience in a related field.
• Advanced level of Spanish and English.
• Significant travel and on-site presence in Egypt, with approximately 50% of the role based in Egypt.

Responsabilidades

• Review all procedures to ensure they are in accordance with cGMP.
• Supervise quality system and quality culture in the Laboratories.
• Ensure investigations for incidents are initiated and root causes analyzed.
• Support internal and external regulatory inspections and audits.
• Manage Plasma Testing Laboratories Quality projects and Change Controls.
• Coordinate tasks across company areas and review new procedures under Change Controls.
• Monitor corrective and preventive actions and quality system indicators.
• Coordinate Quality Risk Management (QRM) studies and mitigation tasks.

Conocimientos

Quality systems

Regulatory compliance

Change Controls

QRM

Root cause analysis

SOP enforcement

Communication skills

Educación

Bachelor’s Degree in Life Sciences

Descripción del empleo

We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities, fostering an inclusive environment where diversity makes us outstanding.

Mission

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

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions).

• 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.
• This position requires significant travel and on-site presence in Egypt, with approximately 50% of the role based in Egypt.

What we offer

It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.

Information about Grifols is available atwww.grifols.com.

Flexibility for U Program

Occasionally Remote.

Benefits package

Contract of Employment:Permanent position.

Grifols is an equal opportunity employer.