Experteer Overview
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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 requested
Responsabilidades
• University xpzdshu 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 improvements
Requisitos principales
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