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Senior Validation Consultant

4 weeks ago

Pune, Maharashtra, India Impetus Career Consultants Private Limited Full time

Hiring Across all the levels

Location : Pune Preferred/ Gurgaon.

Mandatory Skillset :

- Validated systems testing expertise.

- Validated Systems Testing and end to end test management expertise + Strong client engagement.

- Validated Systems Testing and end to end test management expertise.

Responsibilities :

- Contribute to projects overall Computer System Validation deliverables.

- Create and execute test scenarios; select the best testing methodologies, techniques and evaluation criteria for testing.

- Draft, review and approve validation deliverables such as user requirements, technical design specifications, IQ/OQ/PQ scripts and reports, error logs, configuration document, traceability matrix and document 21 CFR Part 11 and EU Annex 11 compliance.

- Build automation scripts and help the leads in the designing/configuring the test automation frameworks.

- Understand the various testing activities: Unit, System, Component, User Acceptance, Performance, Integration and Regression.

- Participate in user story mapping, sprint planning, estimation, and feature walk-throughs.

- Experience in leading junior test analysts, assigning and tracking tasks provided to team members.

- Manage end to end testing / validation lifecycle on applications likes Solution Manager, JIRA, and HP ALM (desired).

- Self motivated, team-oriented individual with strong problem-solving abilities.

- Evaluate risks, assess closure requirements, and process change controls for computerized systems.

- Define key test processes, best practices, KPIs, collateral.

- Well verse with ETL or automation testing.

Qualifications:

- Bachelor's/masters degree in engineering, Science, Medical or related field.

- Hands-on experience in Computer System Validation of Applications and Infrastructure

Qualification :

- A minimum of 3.5-11 years of experience in computer systems validation and hands on experience within GxP (GCP/GMP regulated environment (FDA, EU, MHRA)).

- Experience in managing and leading testing related activities.

- Experience in creating test scenarios and testing protocols (IQ/OQ/PQ/UAT) within the various SDLC or Agile phases as per the standard GxP protocol.

- In-depth understanding of defect management processes.

- Strong SQL skills for data validation and development of expected results.

- Hands on Test Management Tool JIRA and HP ALM.

- Experience in defining risk-based strategies for validation of computerized systems and author review end-to-end CSV documentation in accordance with various test plans.

- Understanding CSV and project related SOPs and WIs.

- Well versed in Good Documentation Practices.

(ref:hirist.tech)