Especialista en Aseguramiento de la Calidad

<p>En Catalent estamos buscando un/a <b>Especialista de Aseguramiento de Calidad</b> para nuestra planta de Loma Hermosa, Buenos Aires.</p><p></p><p><b>Principales Responsabilidades: </b></p><p></p><ul><li>Asegurar el cumplimiento de <b>cGMP</b>, regulaciones vigentes y estándares de calidad de Catalent.</li><li>Coordinar y dar soporte a las actividades del área de QA, priorizando tareas y recursos.</li><li>Gestionar <b>SOPs</b>: redacción, revisión y mantenimiento de documentación del sector.</li><li>Administrar <b>desvíos, investigaciones, reclamos, OOS/OOT</b> y seguimiento de <b>CAPA</b>.</li><li>Coordinar y aprobar <b>batch records</b>, reprocesos, retrabajos y remuestreos.</li><li>Dictaminar certificados de análisis y <b>liberar producto terminado</b>.</li><li>Revisar y aprobar documentación técnica y materias primas de terceros.</li><li>Asegurar entrenamiento del personal y seguimiento de <b>métricas de calidad</b>.</li><li>Mantener comunicación técnica con clientes internos y externos.</li></ul><p></p><p><b>Competencias:</b></p><p></p><ul><li>Manejo de <b>MS Office</b>.</li><li>Conocimiento de <b>cGMP, 21 CFR 210/211, Part 11, ICH</b>.</li><li>Liderazgo, comunicación efectiva, orientación a resultados y al cliente.</li></ul><p></p><p></p><p><b>Formación / Experiencia:</b></p><ul><li>Formación universitaria en <b>Farmacia, Bioquímica o carreras afines</b>.</li></ul><ul><li>Experiencia previa en industria farmacéutica en áreas de Control Calidad/Garantía y/o Aseguramiento de Calidad.</li></ul><ul><li><b>Inglés intermedio.</b></li></ul><p><b>Catalent offers rewarding opportunities to further your career!</b>  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. </p><p>   </p><p>personal initiative. dynamic pace. meaningful work.</p><p>Visit <span><a href="https://careers.catalent.com/us/en" target="_blank">Catalent Careers</a></span> to explore career opportunities.</p><p></p><p>Catalent is an Equal Opportunity Employer, including disability and veterans.</p><p></p><p>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 <a href="mailto:DisabilityAccommodations&#64;catalent.com" target="_blank">DisabilityAccommodations&#64;catalent.com</a>. 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.</p><p>    </p><p>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 &amp; 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.</p><p></p><p>Important Security Notice to U.S. Job Seekers:</p><p>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&#64;catalent.com for us to investigate with local authorities.</p><p></p>