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Full-time computer system validation.

at intellectt in Texas

Role: CSV Engineer

Duration: 12+ Months.



Job Description

• Prepare Work Instructions for the day-to-day activities pertaining to the applications and underlying systems quality review process.

• Ensure knowledge pertaining to new implementations and technologies are adequately shared with the team.

• Ensure adequate monitoring and controls are in place to ensure the stability of the solutions.

• Establish clear communication channels and ensure proper feedback mechanisms are in place with all stakeholders and cross functional teams.

• Support to complete all the required CSV deliverables

• Ensure and coordinate the proper execution of all CSV activities.

• Provides independent review and approval of all CSV deliverables generated during the Software Verification and Validation.

• Reviews test cases with trace matrix and ensures adequate test coverage to challenge the functionality and to determine if the proposed testing would achieve the purpose.

• Reviews executed protocols and reports for adherence with GDP and validation practices, and to determine if the conclusions drawn in the reports are justified.

• Review the impact analysis and resolution provided in incidents/defects.

• Support to identify and forecast the risk of an issue with an appropriate solution.

• Knowledge in Change Management process

• Experienced in corrective and preventive actions (CAPA).

Must Haves:

• Bachelor’s in information technology, Computer Science, Life Sciences, or equivalent educational qualifications

• 5+ years of experience with Medical Device/Pharmaceutical organizations (CM/OEM) in software quality engineering capacity

• Must have knowledge of IT environments and how to maintain applications

• Must have in-depth knowledge of 21CFR Part 11, 21 CFR Part 820 and ISO13485 regulations

• Outstanding oral and written communication skills with a high attention to detail on the review process

Preferred:

• ASQ Certified Quality Engineer.

• Experience in test management tools.

• Experience in usage of DocuSign.
Reference : computer system validation. jobs


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Published at 24-04-2022
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