For one of the global leading biotechnology companies, we are looking for a Senior Associate QA (GMP). For more details about this wonderful opportunity, read the job description below. The company is in Breda, it comes with a one-year contract with extension.
- 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 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 complaint handling process and in audits (internal and third party) as require
- MBO/bachelor’s degree/master’s degree or equivalent
- 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
Project start date:
Short notice preferred
If you are interested in the above description, please apply with your CV and a letter of motivation.
PS: Did you also know that we offer a generous referral scheme, because great people know other great people, right?
For further information, please contact Sayf Idais at +31 (0)20 20 44 502 or by email at firstname.lastname@example.org