Analista de Aseguramiento de la Calidad

Reposted 10 Hours Ago
Be an Early Applicant
Buenos Aires, Ciudad Autónoma de Buenos Aires, ARG
In-Office
Mid level
Biotech • Pharmaceutical
The Role
The Quality Assurance Analyst will manage quality deviations, coordinate investigations, review quality documentation, and ensure compliance with cGMP standards.
Summary Generated by Built In

En Catalent estamos buscando un/a Analista de Aseguramiento de la Calidad para nuestra planta de Loma Hermosa, Buenos Aires.

Principales responsabilidades

  • Gestionar desvíos de calidad, investigaciones, CAPAs y chequeos de efectividad.
  • Participar en investigaciones de reclamos, eventos de calidad y seguimiento de investigaciones de laboratorio y mantenimiento.
  • Coordinar y aprobar reprocesos, retrabajos y remuestreos.
  • Revisar y administrar documentación de calidad: SOPs, batch records, certificados de análisis y archivo documental.
  • Asegurar el cumplimiento de cGMP, políticas y procedimientos de Catalent.
  • Realizar actividades de Aseguramiento de la Calidad en planta productiva.

Competencias:

  • Manejo de MS Office.
  • Conocimiento de cGMP, 21 CFR 210/211, Part 11, ICH.
  • Comunicación efectiva, orientación a resultados y al cliente.

Formación / Experiencia:

  • Formación universitaria en Farmacia, Bioquímica o carreras afines.
  • Experiencia previa en industria farmacéutica en áreas de Control Calidad/Garantía y/o Aseguramiento de Calidad.
  • Nivel de inglés intermedio/avanzado.

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

  • Formación universitaria en Farmacia, Bioquímica o carreras afines
  • Experiencia previa en industria farmacéutica
  • Conocimiento de cGMP, 21 CFR 210/211, Part 11, ICH
  • Nivel de inglés intermedio/avanzado

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

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The Company
HQ: Somerset, NJ
13,715 Employees
Year Founded: 2007

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.

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