Experteer Overview In this role you ensure manufacturing and packaging meet cGMP standards while supporting continuous improvement of QA practices. You will work with cross-functional teams to ensure product quality and regulatory compliance across on-site and third-partyManufacturers. You’ll drive audit activities, change control, deviations, CAPA, and product quality reviews, shaping a robust quality culture. This position offers meaningful impact through safeguarding patient safety and product excellence, within a global, regulated setting.Compensaciones / Beneficios
- Review batch records for accuracy and completeness
- Review and approve Master Batch Records used in manufacturing and packaging
- Disposition and release of products manufactured/packaged on-site or by 3rd party manufacturers & New Product Introduction products
- Collaborate in the execution of cGMP-training programs
- Prepare and participate in the GMP audit program (internal and supplier audits)
- Perform QA activities: change control, deviations, CAPA, and customer complaints
- Support preparation/approval of Product Quality Review reports
- Provide support to operations to handle quality-impacting situations
- Provide support to global projects as requestedResponsabilidades
- University degree in Pharmacy
- Experience as Qualified Person
- Minimum 3 years in pharmaceutical/biotech with knowledge of quality systems, GMP and regulatory requirements
- Experience using SAP
- IT tools and Microsoft Office
- Fluent in English (written and spoken)
- Strong interpersonal and leadership skills
- Quality mindset with ability to detect errors and propose improvementsRequisitos principales
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