R&D QA Audit Specialist

Sant Cugat del Vallès, Catalunya, es
Company: Grifols
Category: Computer and Mathematical Occupations
Published on 2021-06-13 22:04:07

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Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Help us lead one of the world’s largest pharmaceutical companies!

From theBioscience R&D included in the Scientifc Innovation Office, we are looking for an R&D QA Audit Specialist.

The R&D QA Audit Specialist is expected to plan and conduct reviews and audits in support of R&D development programs.

What your responsibilities will be

You will have the opportunity to:

  • Plan and conduct in-depth internal and contract vendors audits and documentation associated with R&D processes and studies, to assess compliance with SOPs, company policy, and applicable regulations and standards.
  • Prepare audit reports and discuss findings with auditees.
  • Track and follow up on the resolution of audit findings.
  • Assist in the conduct of GXP audits as assigned.
  • Provide guidance to R&D staff in resolving QA observations in a compliant manner.
  • Assist internal groups in preparing for inspections by regulatory agencies and participate in on-site regulatory inspections as appropriate.
  • Prepare, review, and in some cases approve SOP reviews and change control requests.
  • Who you are

  • You have a Bachelors’ of Science degree in pharmaceuticals or life sciences.
  • You have knowledge of regulatory requirements and guidance related to GXP (GLP, GCLP, GMP) area of expertise.
  • You have experience in interpretation and implementation of Quality Systems and GXP regulations in R&D.
  • You have ability to define risk as it relates to specific non-conformances or trends and work with auditees to mitigate identified risks.
  • You are communicative, proactive and have ability to have relationship with your stakeholders.
  • You speak advanced level of English.
  • You have experience working with SAP (not mandatory but appreciated). 
  • What we offer

  • Permanent position. 
  • Located in Sant Cugat.
  • This 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. 

    Grifols is an equal opportunity employer.

    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!

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