Computer Systems Validation Expert

1 week ago

Noida, Uttar Pradesh, India hirezy Full time

The Role : (Summary) :

We are seeking an experienced Computer Systems Validation expert to lead validation and testing for Spotfire, Statistica, and Redshift. This is a critical role to ensure that the integration functionality functions as designed and as per regulatory expectations. You will work with a cross-functional team including QC, QA, infrastructure, and other vendors.

Key Responsibilities of the Position :

- Author major validation deliverables in alignment with Moderna and regulatory standards.

- Review and approve CSV deliverables based on identified project deliverables as per defined project phase.

- To identify and prioritize the system requirements, which can be documented in a software requirements specification.

- Communicate interdependencies across multiple teams within own area, drive convergence across these teams to ensure smooth functioning of the teams.

- Manage stakeholder and prepare communications to stakeholders and respond to stakeholder enquiries.

- Develop and maintain detailed validation and testing documentation, including validation plans, test cases, validation protocols, and reports.

- Collaborate with Digital, business, and Quality Assurance teams to understand system requirements and ensure appropriate coverage in testing documentation.

- Ensure all documentation complies with regulatory standards and internal policies.

- Participate in validation and testing activities, providing support in the execution of test cases and recording results.

- Conduct thorough reviews of documentation to identify gaps and ensure accuracy and completeness.

- Assist in the continuous improvement of validation and testing processes and documentation practices.

- Review project and system life cycle documents against quality requirements with regards to good documentation practice (GDP) under the leadership

- GDP review of all project documents is in-scope in aspects of good documentation standards - Templates, Completeness, Coherence.

Required Background :

- Bachelors Degree in Life Sciences, Information Technology, Engineering, or a related field

- Minimum 5 years of relevant job experience in a regulated (GxP) environment

- 5+ years of job-related experience in Computer System Validation

- Experience with Regulatory standards and deliverables

- Hands-on experience with the Spotfire, Statistica, and Redshift

- Proven track record in CSV with a strong understanding of CSV/SDLC practices

- Excellent problem-solving, communication, and documentation skills.

(ref:hirist.tech)

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