VALIDATION SPECIALIST AT GEPD
GrifolsAbout the role
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunity fostering an inclusive environment where diversity makes us be outstanding.
Help us lead one of the world’s largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people. That’s why we need a Validation Specialist - GEPD like you.
Role Mission
Ensure that validations are executed in GEPD with Grifols standards and within the established timeframes
What your responsibilities will be
- Support the new GEDP validation team in managing work teams.
- Prepare documentation (VMP, SOP, validation reports).
- Provide support for the execution of validations to ensure they are carried out properly and on schedule.
- Ensures manufacturing, cleaning, and sterilization validations.
- Develops validation protocols (IQ, OQ, PQ) and final reports.
- Evaluates deviations and proposes corrective and preventive actions (CAPAs).
- Ensure the qualification of production equipment, laboratories, and critical services.
- Review and approve suppliers' technical documentation.
- Ensure compliance with international regulations (FDA, EMA, ISO, ICH, PIC/S).
- Keep documentation and procedures up-to-date with GEPD regulatory changes.
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 accommodations may be made to enable individuals with disabilities to perform the essential functions).
- Bachelor's degree in Biochemistry, Biotechnology, Biomedical Engineering, Health Sciences or related fields.
- Master's degree in the field of science (Biotechnology, Biology, Biochemistry, Chemistry...) (Desirable).
- Excellent verbal and written communication skills in the English and Arab language – C1.
- Availability to travel frequently.
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