Senior Quality Assurance Specialist

4 dagen geleden

Breda, Noord-Brabant, Nederland Hays Voltijd

As a CW Sr Associate QA, you will perform complaint assessments in accordance with internal procedures, regulatory guidelines, and business performance objectives. You will initiate and manage minor deviations related to Product Complaint Inspection (PCI) activities and act as a QA contact for these deviations. You will develop and maintain training materials and work instructions related to PCI processes. You will compile and analyse metrics and maintain departmental performance boards.

You will conduct assessments to support complaint investigations, including return sample inspections and safety feature verifications. You will collaborate with corporate product quality surveillance teams, assessors from other Amgen sites, and contracted partners to resolve product complaint investigations. You will prepare, review, and approve procedures and work instructions to ensure compliance with corporate, site, and regulatory requirements. You will support Amgen Breda projects and improvement initiatives, and provide training to Amgen Breda and affiliate staff on investigations and assessments. You will participate in regulatory inspections and audits related to complaint sample handling processes. You will acquire subject matter expertise in product complaint inspections and engage with relevant stakeholders.

Qualifications

  • MBO or Bachelor's degree in Life Sciences or related field, or equivalent combination of education and experience
  • Knowledge of GMP and GDP, with the ability to apply in both routine and non-routine cases
  • Familiarity with Complaints Management, Deviations, and Quality systems
  • Fluent in English
  • At least 2 years of practical experience in GMP
  • At least 2 years of experience in Quality Assurance or a related field in the pharmaceutical industry
  • Experience in investigations, deviations, and Quality systems is a plus.

What you'll get in return

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

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 focusses 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.

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 jobn't quite right for you, but are you still looking for a new position? Please contact us for a confidential discussion on your career.

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