Analyst

En Catalent estamos buscando un Analista de Compliance en QC para nuestra planta productiva de Buenos Aires

Principales Responsabilidades:

• Brindar soporte técnico y normativo en auditorías internas de clientes e inspecciones regulatorias
• Gestionar investigaciones de resultados fuera de especificación (OOS) desvíos y eventos atípicos asegurando su correcta documentación y cumplimiento de GxP
• Liderar y dar seguimiento a controles de cambios y planes CAPA
• Participar en la actualización de especificaciones y métodos analíticos según compendios oficiales (USP EP entre otros)
• Dar soporte en la calificación mantenimiento y puesta en marcha de equipos de laboratorio
• Revisar y actualizar procedimientos del área (SOPs)
• Participar en actividades de validación y administración de sistemas del área.

El candidato:

• Experiencia en Control de Calidad/Calidad en industria farmacéutica (excluyente)
• Conocimientos en normativas GxP (cGMP cGLP)
• Experiencia en gestión de desvíos OOS y controles de cambios
• Manejo de herramientas informáticas (Excel Word PowerPoint)
• Inglés intermedio (oral y escrito)
• Perfil con orientación a resultados autonomía trabajo en equipo y adaptación al cambio

Beneficios:

• Posibilidades de crecimiento
• Revisión anual del desempeño y proceso de feedback
• 21 días de vacaciones.
• Comedor en Planta

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability you may submit your request by sending an email and confirming your request for an accommodation and include the job number title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment bank details photocopies of identification social security number or other highly sensitive personal information during the offer process and we NEVER do so via email or social media. If you receive any such request DO NOT respond it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.