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Senior Associate QA

Breda | Quality Assurance | Investigations| Complaints | Inspection | Deviations | Regulatory | 1048821

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

As a Senior Associate QA, Product Complaint Inspection (PCI) you will be responsible in initiating and owning minor deviations related to Product Complaint Inspection (PCI) Area activities. You will participate in site regulatory inspections of complaint sample handling process and in audits (internal and third party) as required. You will also perform assessments in support of complaint investigations (e.g. Return sample inspection and Safety Features verification).

In addition to the main responsibilities, you will also be involved with:
  • Own training materials related to PCI processes.
  • Own work instructions related to PCI processes
  • Prepare metrics and own and maintain departmental performance boards
  • Perform assessments in support of complaint investigations (e.g. Return sample inspection and Safety Features verification).
  • Partner with corporate product quality surveillance, assessors from other Amgen sites and contracted partners to resolve product complaint investigations.
  • Additionally, gain subject matter expertise in product complaint inspections and its related stakeholders.

What you'll need to succeed

MBO or BSc in Life Sciences and at least 2 years of practical GMP experience. Minimum 2 years’ experience in QA or related field in the pharmaceutical industry. Working knowledge of GMP and GDP with the ability to apply them in various scenarios. Experience with investigations, deviations, Quality Systems is a plus. Familiarity with Complaints Management, Deviations and Quality processes/systems. Fluent in English.


What you'll get in return

Hays Detachering | You that will start with a contract for 12 months through Hays. Extension to stay within the department is anticipated. At this position, you will get a competitive salary (€4,300 - €4,500 per month) and your travel expenses are fully covered by public transport or max 35KM. Visa sponsorship is not possible in this position and only candidates who can work freely in NL will be considered.


What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

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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Summary

Job type
Temporary
Industry
Pharmaceuticals
Location
Breda
Specialism
Life Sciences
Pay
€4,300 - €4,500 per month
Ref:
1048821

Talk to a consultant

Talk to Eibhlin Hanlon, the specialist consultant managing this position, located in Amsterdam
Hays Amsterdam, Rijnsburgstraat 9-11

Telephone: 0615868143

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