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Senior Associate QA, (Validation / QRM / Quality Engineering)

Breda | QA | GMP | GDP | Change Controls | Process Control |CAPA’s |Equipment Validation | Quality Engineering

Your new company

Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. The company focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, they have grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Your new role

We are seeking a dedicated and experienced Senior Associate QA to join our team. This role involves overseeing the validation of equipment, automation, and information systems, as well as managing Quality Risk Management (QRM) processes. The ideal candidate will ensure compliance with corporate, site, and regulatory requirements while providing guidance to operations staff.

Responsibilities: Working independently, the individual will be responsible for, but not limited to, the following:

  • Collaborate with Product Development, Manufacturing & Engineering, and Information Systems to agree on validation strategies while ensuring GMP compliance.
  • Review and approve validation documentation.
  • Review and approve changes to equipment and M&E procedures.
  • Manage device responsibilities in alignment with GMP regulations.
  • Represent QA in QRM activities, ensuring alignment with corporate policies.
  • Review quality risk assessment summary reports.
  • Conduct final reviews of technical change controls, ensuring comprehensive stakeholder assessments.
  • Act as QA Subject-Matter Expert (SME) to complete QA assessments for technical changes.

What you'll need to succeed

MBO or Bachelor’s degree in Life Sciences or a related field, or equivalent experience.
Minimum of 3 years of relevant experience in the pharmaceutical or medical device industry, specifically in Equipment and Automation Validation. Knowledge of Good Manufacturing Practices (GMP), equipment and automation validation, and computer compliance (Annex 11, Part 11). Familiarity with Non-conformances, CAPAs, and Change Control processes Fluent in English.

What you'll get in return

Hays Detachering | This is a project that will start with a contract for 12 through Hays. Extension to stay within the department is anticipated. At this position, you will get a competitive salary (4,000 – 4,400) and your travel expenses are covered.

What you need to do now

If you are interested in this role, click ‘Apply now’ to send an up-to-date CV, or give us a call! Is this job isn’t quite right for you, but are you still looking for a new position? Please contact us for a confidential discussion on your career.


If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.


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Overzicht

Contractvorm
Tijdelijk
Branche
Pharmaceutisch
Locatie
Breda
Vakgebied
Life Sciences
Salaris
A competitive salary (4,000 – 4,400) and your travel expenses are covered.
Referentie:
1048531

Spreek met een consultant

Spreek met Jordan Burke, de recruiting expert die deze vacature in behandeling heeft, werkzaam in kantoor Amsterdam
Hays Amsterdam, Rijnsburgstraat 9-11

Telefoonnummer: 0630257804

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