Ascensia Diabetes Care Looking for IT Validation Engineer (Quality function) at Delhi, Delhi Full Time

What you will be doing:
Serve as IT project Quality team member as requested in support of business application (IT) and IT infrastructure projects. Train and advise IT project teams on required activities, deliverables, and dependencies to achieve project goals in full compliance with company validation procedures.

Work with business users across departments to evaluate new IT business solutions to establish to what extent, if any, those applications, cloud systems, or infrastructure systems include Quality data, records, or transactions.

Develop project plans including, but not limited to, Quality plans, Validation Plans, and Data Migration Plans. Provide expertise to the IT project team regarding organizational process implementation on the project. Answer questions about software and system development life cycle processes and process compliance issues throughout the project lifecycle.

Interface with supplier and customer Quality personnel on projects to coordinate software regulatory and development processes and deliverables.

Drive formal document peer reviews for project deliverables to minimize documentation defects and set a high bar for documentation quality.

Serve as software/hardware/cloud Subject Matter Expert support on evaluations and audits of suppliers of business software. Prepare supplier software evaluation reports, gap analyses, and risk management plans to ensure that key software suppliers plan and deliver appropriate software and documentation.

Support continuous efforts to improve the organizational software quality system to ensure regulatory compliance, audit readiness and to assure state-of-the-art software development methods.

What you need to succeed:
Experience in business applications for a medical device or other life science company including, but not limited to, software validation requirements for FDA 21 CFR 820, 21 CFR Part 11, ISO 13485, GAMP 5, and AAMI TIR 36.

Experience in Computer Systems Validation

Must be able to “break down” technical IT concepts to engage business users in proactively supporting IT solutions.

Additional assets:
Experience with qualification of on-premise and software-as-a-service IT hardware and infrastructure is preferred.

Application of Six Sigma or Lean methods to support process flow optimization prior to proposal of new business technologies

Experience in a software development environment, with technical software engineering experience (design, coding, testing)

BENEFITS:
Contract of employment

Annual bonus

Private medical care – extended package

Life insurance

Pension Plan

Lunch Card 190 PLN/month

Multicafeteria: Sport Card, Cinema tickets etc.

Employee Assistance Program

Access to LinkedIn Learning

Language classes online

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