Our client is a professional organisation, based in Noord-Brabant Netherlands. This is one of the biggest pharmaceutical company in the world.
Complaints handling (including performing assessments) at our site in accordance with internal procedures, regulatory guidelines and business performance objectives.
Initiate and own product quality complaints, Safety quality investigations and product security investigations for commercial and / or clinical products
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 sites and contracted partners to resolve product complaint investigations
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 Breda projects and improvement efforts as needed
Provide training to 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 complaint handling process and in audits (internal and third party) as required.
MBO or Bachelor’s degree or Master’s degree
Typically 3 or more years of related professional experience
Fluent in English language
Experience in Quality Assurance, including handling product complaints investigations
Experience in pharmaceutical industry
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post.
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