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Resultados de la búsqueda: 34 vacantes
- ...Job Title: CSV & Change Control Specialist Location: Manatí, PR Duration: 6‑month initial term (renewable up to 3 years) Position Overview WeilGroup is seeking two seasoned CSV & Change Control Specialists to support the Business Insights & Technology (BI&T)...SugeridoTrabajar en la oficina
- ...Responsibilities: Author, revise, and maintain SOPs and related controlled documents in accordance with regulatory and company standards.... ...document management systems (EDMS), including version control, approvals, and archival. Support internal and external audits...SugeridoTiempo completo
- ...@abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description Purpose Ensures quality control and quality assurance compliance across the manufacturing site. Serves as an integral member of site leadership team with a focus on...SugeridoTemporalTiempo completo
- For Change management services in the manufacturing area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor in Life Science or Engineering with two (2) years of experience in a biopharmaceutical regulated Industry. Excellent written and verbal skills in both...SugeridoContratoTrabajo por turnos
- Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical...SugeridoTiempo completoCASTrabajar en la oficina
- ...interfaces, networking, printers, report engines, databases and MES system). • Perform software or hardware changes to automation... ...installing it in the user environment. • Evaluates and closes change control requirements and documentation assuring the validated and...SugeridoTurno rotativoTrabajo por turnosFin de semana
- ...Proficient knowledge of computer system life cycle concepts, change control systems, and FDA regulatory requirements, including 21 CFR Part... ..., systems development, and implementation of manufacturing, MES Systems, and quality-related systems. Ability to manage and operate...SugeridoContratoTrabajo por turnos
- ...ISSA, NASM como ejemplos). ~Debe tener CPR, primeros auxilios, y la certificación de DRD (debe ser obtenida dentro de los primeros 6 meses de empleo). Oportunidades de crecimiento disponible – pago por sesión de entrenamiento más comisiones por nuevos clientes....SugeridoContratista
- ...De-trashing, Order processing, and shipping. Second level responsibilities to include, but not limited to the following: Inventory control (FIFO rotation, stock counts, cycle counts and manual monitoring of stock levels and usage). Work stock frequency reports to minimize...SugeridoContratistaTrabajar en la oficina
- ...SOPs, calibration procedures, and policy documentation. Lead corrective and preventive action (CAPA) initiatives and drive quality control improvements. Manage internal and external audits related to calibration and metrology compliance. Supervise lab personnel...SugeridoContratista
- ...(IOQ), Computer System Validation (CSV), Forms and SOP execution services.The resources will work with oversight from the Quality Control Laboratory, Computer System Validation Information Technology team, the Lab Management, and will interact on a regular basis with Engineering...SugeridoTiempo completoDe duración determinadaTrabajar en la oficina
- ...Bachelor ’s degree in Engineering, Computer Systems or related disciplines, combined with at least five (5) years of CSV and Change Control Management within a Pharmaceutical / Biotechnology Environment. Experience in: Change Control Management Reading and...SugeridoContrato
- ...Insights and Technology (BI&T) Department in the following key activities or tasks, such as but not limited to: Develop Change Control records, as required, following Electronic Change Control (e-CC) Procedure for the Manati Site. Perform Computerized System Validation...Sugerido
- ...job) Evaluate and qualify product and process reworks by approved protocols and regulatory requirements. Review and revise controlled documents (e.g., SOPs, work instructions, protocols, batch records) as part of remediation efforts. Support impact assessments...SugeridoContratoTrabajo por turnos
- ...Experience in: Project Management life cycle: Scope of Work, Cost Estimate, procurement, bidding process, scheduling, project control, contractor supervision, and start-up. Managing Manufacturing projects Understanding of pharmaceutical manufacturing processes...SugeridoContratoContratistaTrabajo por turnos
- ...in Excel spreadsheet design and validation. The ideal candidate will play a critical role in analyzing data to support our quality control and validation initiatives, ensuring data integrity and compliance with industry standards. Key Responsibilities: Validation: Develop...Tiempo completo
- ...Experience in: Project Management life cycle: Scope of Work, Cost Estimate, procurement, bidding process, scheduling, project control, contractor supervision and start-up. Managing projects for Utilities, Fire Protection Systems, Lightning Protection, and Purified...ContratoContratistaVisa de trabajoTrabajo por turnos
- ...set standards ~ Make sure that any loose wires are connected and secured properly ~ Ensure calibration of thermostats and other controls ~ Perform checks on motors and belts and handle lubrication duties ~ Change filters and replace any parts as they wear out...Tiempo completoCASInicio inmediatoFin de semana
- ...approved protocols and regulatory requirements. Review and revise controlled documents (e.g., SOPs, work instructions, protocols, batch... ...electronic quality management systems (eQMS) and document control tools. Excellent attention to detail, organizational skills...Contratista
- ...Decommissioning of a temperature monitor sensor (System and Software), among others. Duties will include: Develop Change Control records, as required, following site Electronic Change Control (e-CC) Procedure. Perform Computerized System Validation (CSV)...Contrato
