Amick Brown is seeking an experiencedCSV Engineer forour direct client.
Location: Sunnyvale Duration: 18 Months.
Computer Systems Validation consultant to assist projects in providing expertise in ensuring regulatory compliance across the IT projects and systems.
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.
Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California. Regular full-time employees are eligible for the following Amick Brown provided benefits: