Change Control & Regulatory Specialist

Grifols
Grifols
Parets del vallesPresencialCompetitivoPublicado hace 5 díasTemporal
🇬🇧Inglés requerido
Grifols

Change Control & Regulatory Specialist

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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 opportunities, 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 with a presence in more than 100 countries, and a growing global team of over 20.000 people. That's why we need a Change Control & Regulatory Specialist like you.

Mission

Develop functions related to the preparation, evaluation, and follow-up of technical-regulatory and registration documentation, as well as providing technical-regulatory advice to other areas of the Company. Coordinate and technically oversee change controls, assessing the potential impact of their implementation on products and on regulatory licenses/marketing authorizations. Manage technical agreements with other companies within the group as well as with external partners.

What your responsibilities will be

  • Coordination and Technical Oversight of Change Controls:
    • Lead, coordinate, and technically oversee all change controls. Ensure that changes are properly assessed, documented, justified, and implemented in alignment with regulatory, quality, and operational requirements. Act as the primary point of contact between cross‑functional teams to guarantee timely and compliant execution.
  • Review and Verification of manufacturing recipes:
    • Perform verification of manufacturing master recipes whenever changes are applied. This includes assessing the accuracy, consistency, and compliance of recipe configurations, as well as ensuring alignment with manufacturing workflows, quality standards, and digital validation requirements.
  • Review, Optimization, and Maintenance of Change Management Procedures:
    • Regularly review, maintain, and improve internal procedures related to change management. Ensure that processes remain robust, efficient, and aligned with current GMP guidelines and corporate quality standards. Provide guidance and training to stakeholders involved in the change management lifecycle to foster a culture of compliance and continuous improvement.

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).

  • You have a Bachelor's Degree in Health Sciences or engineering.
  • You have experience in technical departments within the pharmaceutical industry.
  • You have organizational and planning skills.
  • Ability to adapt and solve problems.
  • Effective stress management and teamwork capabilities.
  • Strong communication skills for interacting with other departments or areas.
  • You have Advanced level of Spanish and English (C1) and of MS Office (Excel).

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 at www.grifols.com. If you are interested in joining our company and you have what it takes for such an exciting position, then don't hesitate to apply!

We look forward to receiving your application!

We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.

Grifols is an equal opportunity employer.

Flexibility for U Program: Hybrid Model

Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time).

Benefits package

Contract of Employment: Temporary position

Location: Parets del Vallès.

www.grifols.com

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Location: SPAIN : España : Parets del Valles:[[cust_building]]

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