CSV Engineer puesto de trabajo vacante en la Sunnyvale, California DGN Technologies

Vacancy caducado!

Roles and Responsibilities: • Maintains responsibilities for ensuring GxP computerized systems operate within the framework of regulations (GxP, 21CFR11, etc.), applicable Quality Modules, and requirements defined in local procedures.• Provide direct oversight for computer system validation from a quality assurance perspective to ensure quality and compliance requirements are met.• Provide guidance on CSV validation/quality issues and discrepancies. Support investigation of CSV defects and quality records (deviation, CAPAs).• Review CSV Validation deliverables for all projects assigned from regulatory compliance standpoint.• Ability to have working knowledge on Microsoft products (Word, Excel) and testing tools (Ex: HP ALM, Load Runner)• Provide support to external and internal audits related to computerized system validation activities as needed• Advice a cross functional team in an efficient manner, including but not limited to excellent communication and time management skills to share responsibilities and expectations, and accomplishing goals throughout timelines.• To perform Periodic Reviews quarterly on the systems that are scheduled for each quarter.• Partnering with internal and external teams; sharing information to increase the collective understanding of QA and Compliance programs.• Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5.• Ensuring alignment of processes, procedures and methods across multiple organizations (internal and external).• Ensuring systems are fully implemented and integrated with other quality management systems, site and global functions.• Authoring and /or revising SOPs as and when needed• Ability to provide guidance on revising validation documents and protocols.• Interacts with senior internal personnel and external partners on significant matters often requiring coordination across facility locations.• Contribute to projects related to CSV improvements.• Support the Compliance team on computerized system audits to ensure compliant vendor/supplier management program and services.

Vacancy caducado!

ID	#45712999
Estado	California
Ciudad	Sunnyvale
Tipo de trabajo	Contract
Salario	USD $60 - $80 60 - 80
Fuente	DGN Technologies
Showed	2022-09-15
Fecha	2022-08-24
Fecha tope	2022-10-23
Categoría	Etcétera
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Job Details

CSV Engineer

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