For one of the biggest biotechnology companies worldwide we are looking for a Senior Associate Quality Assurance (GMP). You will be responsible for assisting in various projects, reviewing batch records, provide training to staff and many more in the job description below! The company is in Breda, and it comes with a 1-year contract with possibility for extension.
- Initiate and own product quality complaints, Safety quality investigations and product security investigations for their 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 departments and contracted partners to resolve product complaint investigations
- Partner with company affiliates in country and intake call centres 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 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 required.
- Three or more years of related professional experience
- Bachelor’s or master’s degree
- Fluent in English language.
- Experience in QA and handling product complaints investigations (Preferred)
- Experience in pharmaceutical industry (preferred)
Project start date:
Short notice preferred
1 year + extension possible.
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 email@example.com