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Computer Systems Validation Expert - Spotfire / Statistical / Redshift

Altrion technologies private limitedIndia

20 days ago

Job description

Position : - Computer Systems Validation Expert - : ( Onsite)

Duration : Fulltime

Position Summary :

We are urgently seeking an experienced Computer Systems Validation (CSV) Expert to lead validation and testing efforts for Spotfire, Statistica, and Redshift platforms.

This position plays a vital role in ensuring that integrated systems operate as intended and in full compliance with regulatory standards. The CSV Expert will collaborate with cross-functional teams, including Quality Control (QC), Quality Assurance (QA), Infrastructure, and external vendors.

Key Responsibilities :

Author major validation deliverables in accordance with Moderna's and regulatory standards.
Review and approve CSV deliverables based on defined project milestones.
Identify and prioritize system requirements; document them in a Software Requirements Specification (SRS).
Facilitate communication and drive convergence across multiple interdependent teams.
Manage stakeholder communication and address inquiries effectively.

Develop and maintain comprehensive validation documentation, including :

a. Validation Plans

b. Test Cases

c. Validation Protocols

d. Validation Reports

Collaborate with Digital, Business, and QA teams to align testing documentation with system requirements.

Ensure all documentation adheres to regulatory requirements and internal compliance policies.

Participate in validation execution, support test case execution, and record results.

Perform detailed documentation reviews to ensure completeness, accuracy, and compliance.

Contribute to the continuous improvement of validation / testing methodologies and documentation standards.

Conduct GDP (Good Documentation Practice) reviews of all lifecycle documents.

Ensure compliance with documentation standards regarding templates, completeness, and coherence.

Required Qualifications :

Bachelor's degree in Life Sciences, Information Technology, Engineering, or a related field.

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

At least 5 years of hands-on experience in Computer System Validation.

In-depth knowledge of regulatory standards and compliance deliverables.

Proven experience with the following systems / tools :

a. Spotfire

b. Statistica

c. Amazon Redshift

Strong understanding of CSV, Software Development Life Cycle (SDLC), and system integration principles.

Excellent problem-solving skills with strong communication and documentation abilities.

(ref : hirist.tech)

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Computer System Validation • India