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Qualified Person (QP) / Team Lead
For our client, a globally leading pharmaceutical organisation with a specialized radiopharmaceutical manufacturing site, we're looking to recruit a Qualified Person / QA Team Lead to ensure the timely and compliant release of radiopharmaceutical products and lead a team of QA specialists. This position is specifically interesting as you will combine your QP responsibility with a leadership role, in an innovative and fast-growing therapeutic field where reliable supply has a direct impact on patients.
Pharmaceutical
Quality/RA
Baarle-Nassau - Netherlands
40 uur per week
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Jouw consultant
Over jouw rol
Zo maak jij het verschil
- Release radiopharmaceutical products manufactured on site in a timely manner, in close partnership with Supply Chain
- Release batch analyses in line with the Marketing Authorisation, Directive 2001/83/EC and national regulations
- Lead, coach and develop a team of 4 to 6 QA specialists
- Ensure deviations, CAPAs, change controls and complaints are properly investigated, escalated and resolved
- Provide quality oversight of validation and qualification status, equipment, training and QMS activities
- Write, review and approve GMP documentation, including procedures, protocols and the Quality Manual
- Act as Subject Matter Expert during health authority inspections and internal and external audits
- Deputise for the Quality Operations Manager and provide shift or on-call support when required
Wat nodig is
Wat jij mee brengt
- Master's degree in a scientific discipline, preferably Pharmacy
- At least 3 years' experience as a QP or in a QA role within the pharmaceutical or biotechnology industry
- Strong knowledge of GMP and applicable European and Dutch pharmaceutical regulations
- Experience in, or a clear ambition for, leading and coaching a team
- An agile mindset focused on collaboration and continuous improvement
- Fluency in English, both written and spoken
- Willingness to provide shift or on-call support when needed
- Based within commuting distance of the site in the south of the Netherlands (relocation is not supported)
Wat wij bieden
Jouw voordelen
- Competitive annual gross base salary, depending on experience and competencies
- Performance-based bonus
- Comprehensive benefits, including pension and insurance plans
- A minimum of 14 weeks' paid parental leave
- Access to wellbeing resources and global recognition programmes
- Leadership experience in a specialised, future-focused field
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