Experteer Overview
Si le interesa solicitar este empleo, por favor, asegúrese de cumplir los siguientes requisitos que se enumeran a continuación.
Join Almirall’s Quality Partners Market Specialist to ensure partner operations meet GMP/GDP and local regulations. You will implement quality systems for distribution through partners and drive cross-functional quality initiatives. You’ll manage deviations, OOS, change control, audits, and Quality Agreements between manufacturers and partners. You will stay current with local regulations and implement new GXP changes, contributing to continuous improvement per ICH Q10. This role blends regulatory excellence with collaborative problem-solving to protect patient safety and product quality.
Compensaciones / Beneficios
• Apply corporate quality policy to API, medicinal products, medical devices, and cosmetics in partner distribution
• Establish and apply procedures for the quality system linked to partner distribution
• Participate in cross-functional projects and quality initiatives within Almirall
• Manage GMP/GDP activities and regulatory compliance in countries where products are marketed
• Oversee GMP/GDP elements such as deviations, OOS, and change control between Manufacturer and Partner
• Execute GMP/GDP audit qualification plans to maintain partner quality standards
• Ensure and maintain Quality Agreements with Partners
• Maintain updated local regulatory information and coordinate implementation with manufacturers
• Implement new GXP regulations within scope
• Drive continuous quality improvement xpzdshu in line with ICH Q10
Responsabilidades
• Bachelor in Life science
• 1-3 years quality-related experience in pharmaceutical or biopharmaceutical industry
• Knowledge of GMP/GDP and regulatory requirements (EU, FDA, ICH, MFDS, EAEU)
• Technical working proficiency in quality systems
• Experience with Trackwise and eDMS
• Ability to influence and collaborate with others
• Advanced written and spoken Spanish and English
Requisitos principales
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