Senior Quality Assurance Associate

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. They have reached millions of patients around the world and are developing a pipeline of medicines with breakaway potential.

Your new role

Are you looking for a new role where you can provide QA guidance and support in the complaints department? We are looking for someone who can:

Perform assessments in support of complaint investigations (e.g. batch record review, reserve sample inspection, Return sample inspection and Safety Features verification)
Partner with corporate product quality surveillance, assessors from other company sites and contracted partners to resolve product complaint investigations
Partner with other company affiliates in the country and intake call centres on call intake procedures and complaint investigations
Prepare, review and approve procedures or work instructions in compliance with corporate, site and regulatory requirements
Assist in Breda projects and improvement efforts as needed
Provide training to ABR and affiliate staff on complaint handling procedures and performing investigations/assessments
Initiate and own QA Non Conformances/CAPAs as needed
Participate in site regulatory inspections of complaints, handling process and in audits (internal and third party) as required.

What you'll need to succeed

MBO or B.Sc. degree in Life Sciences with 3 years' QA / quality related to manufacturing in a pharmaceutical environment with experience in handling product complaints and investigations. Working knowledge and hands-on experience with GMP, GDP and or GCP. Experience in a manufacturing environment is highly desirable. Excellent communication skills in English. 100% commitment, willingness to work in shifts. Night shifts are non-negotiable.

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, shift allowance and your travel expenses are fully covered by public transport. 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 are interested in this role, click ‘Apply now’ to send an up-to-date CV, or give us a call! If this job isn’t quite right for you, are you still looking for a new position? Please contact us for a confidential discussion about your career.

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