Computer system validation

Greeting from HCL!

Currently Hiring for Computer System Validation - Medical Device

We are looking for

• Medical Devices related CSV exposure
• Medical Devices related Quality Management
• Mergers and Acquisitions related CSV which include application/database migration, application disposition and cloud migration etc.

Role- CSV Lead

Computer System Validation, GxP Regulations

Validation experience with R&D and Clinical Systems, Infrastructure Qualification

• Experience in validating R&D and Clinical Systems
• 3+ years experience with System Development Lifecyle 7+ years experience in Computer System Validation (Based on the role selected)
• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation
• Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports
• Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
• Preferred tools knowledge and experience: JIRA, ServiceNow, XRAY and Change Record review
• Experience in Acquisition, Separation and Divestiture
• Experience in Infrastructure Qualification
• Should be experienced in Test scripts, executions and defect reviews.
• Strong verbal and written communication skills.
• Ability to work as a team player, lead a team or accomplish tasks without supervision.
• Ability to work with remote teams and support several changes/projects simultaneously.
• Ability to provide Validation guidance, timely reviews, and escalations to TQ management.

Key Responsibilities

Shown on internal and external posting

Section content, to edit press enter.1. To develop and deliver ,detailed solutions through consulting project activities 2. To perform qualitative and/or quantitative analyses to assist in the identification of client issues and the development of client-specific solutions 3. To coordinate with Internal and external stakeholders to ensure effective deliver of client specific solution 4. To design,structure and deliver reports and presentations that are appropriate to the characteristics or needs of the audience 5. To cultivate successful customer relationships1. To develop and deliver ,detailed solutions through consulting project activities

2. To perform qualitative and/or quantitative analyses to assist in the identification of client issues and the development of client-specific solutions

3. To coordinate with Internal and external stakeholders to ensure effective deliver of client specific solution

4. To design,structure and deliver reports and presentations that are appropriate to the characteristics or needs of the audience

5. To cultivate successful customer relationships

Interested candidate please drop mail to [Confidential Information]

Regards,

Kushma

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