Analista de Aseguramiento de la Calidad at Catalent Boston

San Jerónimo, Antioquia, Colombia -

Full Time

Start Date

Immediate

Expiry Date

30 Jul, 26

Salary

0.0

Posted On

01 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, cGMP, 21 CFR 210/211, Part 11, ICH, Quality Investigations, CAPA, SOP Management, Batch Records, Certificate of Analysis, Laboratory Investigations, MS Office, Effective Communication, Result Oriented, Customer Oriented

Industry

Pharmaceutical Manufacturing

Description

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 DisabilityAccommodations@catalent.com. 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 spam@catalent.com for us to investigate with local authorities.

How To Apply:

Incase you would like to apply to this job directly from the source, please click here

Responsibilities

The analyst will manage quality deviations, investigations, CAPAs, and effectiveness checks while ensuring compliance with cGMP and internal policies. They are also responsible for reviewing quality documentation and coordinating reprocessing and sampling activities in the production plant.