For our client in Breda we are looking for a Senior Associate QA (GMP).
Job description
Complaints handling (including performing assessments) at the office in Breda in accordance with internal procedures, regulatory guidelines and business performance objectives.
Responsibilities
- Initiate and own product quality complaints, Safety quality investigations and product security investigations for our client 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 our client 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 our clients Breda projects and improvement efforts as needed
- Provide training to ABR and our client 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.
Requirements
Minimum Requirements
- MBO or Bachelor’s degree or equivalent
- Typically 3 or more years of related professional experience
- Fluent in English language.
OR
- Master’s degree or equivalent
- Minimal related professional experience
- Fluent in English language.
Preferred Requirements
- Experience in Quality Assurance, including handling product complaints investigations
- Experience in pharmaceutical industry
- Benefits (optional)