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 7,000 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 [email protected]. 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 [email protected] for us to investigate with local authorities.
Skills Required
- Experiencia en Control de Calidad/Calidad en industria farmacéutica
- 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)
- Orientación a resultados, autonomía, trabajo en equipo y adaptabilidad al cambio
Catalent, Inc. Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Catalent, Inc. and has not been reviewed or approved by Catalent, Inc..
-
Leave & Time Off Breadth — Paid time off is commonly described as roughly 152 hours per year plus about eight paid holidays for U.S. roles. Eligibility and exact counts vary by location, but the allotment is positioned as competitive.
-
Retirement Support — A 401(k) with a company match (often described as dollar‑for‑dollar up to 6%) is part of the package. The match level is commonly referenced as a meaningful component of total rewards.
-
Inclusive Benefits Coverage — Medical, dental, vision, life/disability, HSA/FSA, EAP, tuition reimbursement, adoption assistance, commuter and dependent‑care benefits, and wellness programs are offered. Some roles indicate benefits eligibility begins on the first day for direct hires.
Catalent, Inc. Insights
What We Do
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. For more information, visit www.catalent.com.
