Analista Sr. de Calificaciones y Calibraciones at CATALENT CTS SINGAPORE PRIVATE LIMITED

San Jerónimo, Antioquia, Colombia -

Full Time

Start Date

Immediate

Expiry Date

24 Jan, 26

Salary

0.0

Posted On

26 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Documentation, GMP, Quality Management Systems, Calibration, Validation, CSV, Pharmaceutical Industry, Database Knowledge, English Language

Industry

Pharmaceutical Manufacturing

Description

En Catalent estamos buscando un Analista Senior de Calificaciones y Calibraciones para nuestra planta productiva de Loma Hermosa, Buenos Aires. Principales Responsabilidades: Redactar y revisar documentación asociada al Sector Calificaciones, Calibraciones y CSV (protocolos, reportes, master planes individuales, procedimientos, entre otros). Coordinar, seguir y revisar las actividades del sector de Calificaciones, Calibraciones y CSV realizadas por proveedores de servicios externos. Mantener actualizado el estado calibrado de los instrumentos. Mantener actualizado el estado calificado de equipos, áreas y servicios. Utilizar los sistemas de calidad que utiliza la planta (sistema de gestión de mantenimiento; controles de cambio; seguimientos; correcciones y desviaciones, entre otros) proveyendo información y realizar evaluaciones iniciales asociadas. Redactar, revisar y ejecutar tareas asociadas a validaciones de sistemas computarizados Proponer mejoras para las actividades del área. El candidato: Técnico, analista de sistemas o estudiante de Ingeniería, Farmacia, Bioquímica, Química o afines a la industria farmacéutica Experiencia en actividades bajo entorno GMP y sistemas de gestión de calidad, utilizando buenas prácticas de documentación en la industria farmacéutica Conocimiento básico de base de datos Idioma: Inglés Intermedio Beneficios: Posibilidades de crecimiento Cobertura Médica 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 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.

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Responsibilities

The Senior Analyst will draft and review documentation related to qualifications, calibrations, and CSV. They will also coordinate and review activities performed by external service providers and maintain the calibration status of instruments and equipment.