SI2 Technologies

About SI2 Technologies

Responsibilities and Duties 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 issues and discrepancies. Support investigation of CSV defects and quality records (deviation, CAPAs). Review CSV Validation activities including deliverables from regulatory compliance standpoint. Provide support to external and internal audits related to computerized system validation activities. 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. Help, establish and sustain computer system validation global policies and standards that incorporate industry best practices and are health authority compliant. 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. Ability to provide guidance on revising validation documents and protocols. · Administer applicable electronic systems. Assist as needed in audits and inspections. 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. Job Type: Full-time Experience: work: 6 years (Preferred) total work: 6 years (Preferred)

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Company Info

Legal Form: Inc

Company Type: Public

Company Size: 11 - 50

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