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Computer Systems Validation Engineer : 20-00579
Ref No.: 20-00579
Category: Quality Assurance and Testing
Location: Sunnyvale, California
Primary Skills: 21 CFR Part 11, Part 820, Annex 11, GAMP5, System Validation, CSV Validation, Audits, Inspections
Duration: Long Term
Contract Type: W2 Only

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 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.
  • Experience in 21 CFR Part 11, Part 820, Annex 11, GAMP5
       To follow up with any questions, please contact Vaibhav at 408-512-2355

Akraya is an award-winning IT staffing firm and the staffing partner of choice for many leading companies across the US. We offer comprehensive benefits including Health Insurance (medical, dental, and vision), Cafeteria Plan (HSA, FSA, and dependent care), 401(k) (enrollment subject to eligibility), and Sick Pay (varies based on city and state laws).
 
If this position is not quite what you're looking for, visit akraya.com and submit a copy of your resume. We will get to work finding you a job that is a better fit at one of our many amazing clients.
 
Akraya is committed to equal treatment and opportunity in all aspects of recruitment, selection, and employment without regard to gender, race, religion, national origin, ethnicity, disability, gender identity/expression, sexual orientation, veteran or military status, or any other category protected under the law. Akraya is an equal opportunity employer; committed to a community of inclusion, and an environment free from discrimination, harassment, and retaliation.