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computer system validation
at intellectt in T'ai-chung
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
Reference : computer system validation jobs
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Published at 24-04-2022
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Viewed: 246 times