Objective of the role is Complaints handling (including performing assessments) 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 projects and improvement efforts as needed
- Provide training to ABR 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.
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent.
- MBO or Bachelor’s degree or equivalent
- Typically 3 or more years of related professional experience
- Fluent in English language
- Master’s degree or equivalent
- Minimal related professional experience
- Fluent in English language.
- Experience in Quality Assurance, including handling product complaints investigations
- Experience in pharmaceutical industry
- Location: Breda
- Working 1-2 days/week on site is expected
- Long-term contract
- Full time