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Validation Specialist At Gepd 526047

Grifols

Madrid

Presencial

EUR 40.000 - 80.000

Jornada completa

Hace 30+ días

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Descripción de la vacante

An established industry player in healthcare is seeking a Validation Specialist to join their international team. In this pivotal role, you will ensure that validations are executed according to company standards and within set timeframes. Your responsibilities will include developing validation protocols, evaluating deviations, and ensuring compliance with international regulations. This position offers a fantastic opportunity to enhance your career in a supportive environment that values diversity and professional growth. If you are proactive, methodical, and eager to learn, this role could be your next big step.

Servicios

Benefits package
Professional development opportunities
Diversity and inclusion initiatives

Formación

  • Minimum 1 year of experience in validation areas within the pharmaceutical sector.
  • Knowledge of GMP environment is essential.

Responsabilidades

  • Ensure validations are executed in GEPD with Grifols standards.
  • Develop validation protocols (IQ, OQ, PQ) and final reports.
  • Ensure compliance with international regulations (FDA, EMA, ISO).

Conocimientos

Python
Debugging
C / C++
Technical Writing
FDA Regulations
Minitab
GAMP
OS Kernels
Perl
cGMP

Educación

Bachelor's degree in Biochemistry
Master's degree in a science field

Herramientas

MS Office

Descripción del empleo

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 wellbeing of people around the world. We are leaders in plasma-derived medicines and transfusion medicine, developing, producing, and marketing 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 outstanding.

Help us lead one of the world's largest pharmaceutical companies. We are a world leader in plasma-derived medicines, present in more than 100 countries, with 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 GEPD validation team in managing work teams.
  • Provide support for validations to ensure they are carried out properly and on schedule.
  • Ensure manufacturing, cleaning, and sterilization validations.
  • Develop validation protocols (IQ, OQ, PQ) and final reports.
  • Evaluate deviations and propose 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 a science field (Biotechnology, Biology, Biochemistry, Chemistry) is desirable.
  • Excellent verbal and written communication skills in English and Arabic (C1 level).
  • Availability to travel frequently.
  • Minimum 1 year of experience in validation areas within the pharmaceutical sector.
  • User-level skills in MS Office.
  • Knowledge of GMP environment is essential.
  • You are proactive, methodical, and eager to learn.
What we offer

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

Information about Grifols is available. If you are interested in joining our company and have what it takes for such an exciting position, don't hesitate to apply!

We look forward to receiving your application!

Grifols is an equal opportunity employer.

Third Party Agency and Recruiter Notice

Agencies presenting candidates to Grifols must have an active, non-expired Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions they have been engaged for by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law. We will consider all qualified applicants in accordance with applicable laws.

Schedule: Monday to Thursday, 7:10 to 16:19, and Friday 8:15.

Benefits package included.

Professional Group: 6

Contract Type: Permanent position

Learn more about Grifols.

Required Experience: Unclear Seniority

Key Skills

Python, SOC, Debugging, C / C++, FDA Regulations, Minitab, Technical Writing, GAMP, OS Kernels, Perl, cGMP, Manufacturing

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