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Validation Intern

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Grifols

Jan 16, 2024

Applications are closed

  • Internship
    Full-time
    Off-cycle Internship
  • Data
    Science
  • Dublin

Requirements

  • Strong interpersonal skills for interactions with other departments.
  • Studying for a Degree in Science/Engineering
  • Desirable:
  • Experience in representing client companies during internal (Corporate) audits and external (FDA and HPRA) audits
  • Working knowledge of HTM 01 (Part C, Steam Sterilization) Autoclaves
  • Familiarity with ISO-14644 (Cleanrooms and Associated Environments)
  • Familiarity with Annex 1 (Manufacture of Sterile Medicinal Products)
  • Experience within aseptic manufacturing environment
  • Experience in a Quality or Validation Role within Pharma sector
  • Experience with Software validation for manufacturing
  • Excellent Technical Writing and analytical skills.
  • Familiarity with cGMPs and industry and federal guidelines required.
  • Experience with Word, Excel and Access computer applications.

Responsibilities

  • Write, review and execute Validation Protocols and Reports (for Equipment, Utilities, Processes, Cleaning, Temperature Mapping and Equipment Software) ensuring compliance to all relevant global and local quality and validation procedures/standards
  • Generation and review of project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures.
  • Supporting validation activities including review of documentation and hands-on execution of validation activities (FAT, SAT, IQ, OQ, PQ etc) to ensure equipment meets current GMP requirements and industry standards.
  • Maintain the Site Validation Master Plan (VMP) and associated Project VMP’s, defining the validation approach associated with each piece of equipment, system, process and the requalification requirements including study requirements and frequency. Execute/Co-ordinate Re-Validation activities as required.
  • Performs other validation associated activities as defined by Manager or Director.
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Grifols

Innovating for patients and society

Manufacturing & Electronics
Industry
10,001+
Employees
1909
Founded Year

Mission & Purpose

Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people all over the world. A leader in essential plasma-derived medicines and transfusion medicine, we develop, produce and provide innovative healthcare services and solutions in more than 110 countries. Patient needs and our ever-growing knowledge of many chronic, rare and prevalent diseases, sometimes life-threatening, drive our innovation in plasma-based therapies and other biopharmaceuticals to enhance quality of life. Grifols is focused on treating conditions across a broad range of therapeutic areas: immunology, hepatology and intensive care, pulmonology, hematology, neurology and infectious diseases. With a workforce of over 24,000 employees in more than 30 countries and regions, we are committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership in the industry. Our work has a positive social and economic impact in the countries where we operate, creating jobs and generating wealth. People are at the heart of what we do, and we strive to create an inclusive, diverse, fair and equal society. Maintaining and promoting a workforce that reflects this reality leads to enhanced professional relationships and helps us to give our best to patients, donors and customers. In 2022, Forbes has recognized Grifols as one of the “Best Employers for Women,” one of “America’s Best Large Employers” and one of the “75 Best Companies to Work for” in Spain. To maintain a positive community and overall respectful communication, please keep our community guidelines in mind. You will find a full version of our guidelines at https://www.grifols.com/en/grifols-social-media-community-guidelines