Your new role
In this role you will Initiate and own product quality complaints, Safety quality investigations and product security investigations for commercial and/or clinical products . You will perform assessments in support of complaint investigations & partner with corporate product quality surveillance, assessors from other company sites and contracted partners to resolve product complaint investigations. Important part of your role will be to Partner with affiliates in country and intake call centers 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 local projects and improvement efforts as needed and provide training to staff on complaint handling procedures and performing investigations/assessments. You will have the ownership of QA Non Conformances/CAPAs as needed. Lastly you will participate in site regulatory inspections of complaint handling process and in audits (internal and third party) as required.
What you'll need to succeed
A successful candidate holds a Bachelor or MSc degree in Life sciences or related field education. GDP (Good Distribution Practice) and GMP knowledge is also essential in order to interpret and apply in both routine and non-routine cases daily. Fluency in English, and any additional language will be a plus.
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.
What you'll get in return
Hays Detachering | This is a project that will start with a contract for 1 year through Hays. Extension to stay within the department is anticipated. At this position, you will get a competitive salary and your travel expenses are covered.
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. #1045039
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CDD (option CDI)
Contacter un consultant
Contactez Anna-Maria Oikonomou, le consultant en charge de cette offre d'emploi, situé à Amsterdam