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- ...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
- ...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
- ...services.The resources will work with oversight from the Quality Control Laboratory, Computer System Validation Information Technology... ...PR Education: Bachelor's degree or higher in Chemistry/ Biology/ Microbiology/ Computer Science/ Information Systems/ Engineering...SugeridoTiempo completoDe duración determinadaTrabajar en la oficina
- ...assessments on SOPs, forms, and systems. Manage and document change controls following site procedures. Develop an implementation... ...Requirements: Bachelor’s degree in Chemical Engineering, Biology, Pharmacy, Microbiology or related sciences. Minimum of 6 years...SugeridoTrabajar en la oficinaTurno rotativoTrabajo por turnosFin de semana
- ...upgrade project. Qualifications BS or higher in Chemistry/ Biology/ Microbiology/ Computer Science/ Information Systems/... ...training in validation methodologies, technologies, and process control computer systems. Knowledge on computerized system with data...SugeridoContratoTrabajar en la oficina
- ...with cross-functional stakeholders including Engineering, Quality Control, IT, and Quality Assurance to ensure successful planning,... ...Required Qualifications: Bachelor’s degree or higher in Chemistry, Biology, Microbiology, Engineering, Computer Science, or a related...SugeridoContratoTrabajar en la oficinaInicio inmediatoTrabajo por turnosFin de semana
- ...Preferable, in the pharmaceutical or distribution environment. (Operations including receiving, picking, packing, shipping, and inventory control.) One year of strong leadership, communication, and organizational skills. Strong computer skills, including proficiency in...SugeridoContratistaTrabajar en la oficina
- ...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
- ...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...SugeridoContratoContratistaVisa de trabajoTrabajo 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
- ...fabricators & refiner reconciliations, freight management, permanent investment, Taxes, SURI, metals accounting, cycle count, inventory control, refining tasks and cost related tasks. In addition, this role is responsible for reconciliations between systems to ensure all...SugeridoTiempo completoEmpleo permanenteTrabajar en la oficina
- ...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)...SugeridoContrato
- ...requirements and internal EHS policies. Conduct field inspections, issue work permits, and correct unsafe conditions. Quality Control & Issue Resolution Confirm installations meet engineering specifications and GMP standards. Lead conflict resolution among...SugeridoContratistaSubcontratistaVisa de trabajo
- ...Coordinate with external consultants and internal resources to ensure timely document generation and execution. Manage change controls and deviations related to plants and equipment. Support maintenance and calibration functions to improve compliance and quality...SugeridoTiempo completo
- ...utilities. Develop and execute IQ, OQ, and PQ protocols; compile FAT/SAT documentation. Automation & Controls Commission and validate BAS/SCADA control systems and HMI interfaces; test control logic and network communications. Support data historian integration...SugeridoContratistaTrabajar en la oficinaTrabajo 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...Tiempo completoCASTrabajar en la oficina
- ...configurations to assure software works as expected before installing it in the user environment. • Evaluates and closes change control requirements and documentation assuring the validated and compliance state of the environments. • Assist on quality events investigations...Turno rotativoTrabajo por turnosFin de semana
- ...AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Proficient knowledge of computer system life cycle concepts, change control systems, and FDA regulatory requirements, including 21 CFR Part 11. Proven experience issuing and preparing Computerized Functional...ContratoTrabajo por turnos
- ...the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipments, tools, or controls. The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and smell...Tiempo completoTurno de mañana
- ...improvements are achieved. Qualifications ~ Bachelor’s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) ~6 years in Quality Assurance, Compliance and Auditing with project management experience within...TemporalTiempo completoContrato
- ...the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipments, tools, or controls. The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and smell...Tiempo completoCAS
- ...Experience in: Project Management life cycle: Scope of Work, Cost Estimate, procurement, bidding process, scheduling, project control, contractor supervision, and start-up. Understanding of pharmaceutical manufacturing processes, regulations, and industry best practices...ContratoContratistaTrabajo por turnos
- ...and/or reduce cycle time per established procedures. Learns traceability and inspection requirements, learns statistical process control criteria. Assists engineers in collecting, compiling, measuring, organizing and recording data, and by writing procedures. May...ContratoTrabajo por turnos
- ...regulatory requirements. ~ Experience with equipment, process, or software validation (depending on scope). ~ Familiarity with design control and product lifecycle documentation. ~ Strong technical writing, organizational, and communication skills. ~ Fluent in English...
- ...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
- ...including concept generation, design, prototyping, and testing. Create and maintain design documentation in accordance with design control procedures (e.g., DHF, DMR, Risk Analysis, Design Inputs/Outputs). Conduct feasibility studies and validation activities (e.g.,...Práctica
- ...production of final parts, components, sub-assembly and assembly. Determines and can assist in the development of methods and procedures to control or modify the manufacturing process. Work with engineers conducting experiments. Nance functions associated with all...Por horaPrácticaTemporalTiempo completoTrabajo por turnosFin de semanaLunes a viernes
- ...results of non-conforming product to identify causes, implements controls to eliminate causes, and assesses the success of the controls.... ...quality specifications and standards. Supervision and control of production processes to ensure they are carried out according...ContratoTrabajo por turnos
- ...impact assessments. Provide alternatives to resolve documentation situations. Establish project communication and documentation controls. Assure consistent quality of activities that meets or exceeds the requirements. Qualifications ~ Bachelor in Science...ContratoTrabajar en la oficina
- ...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