Primary Skill (Only 1 skill can be selected as primary)
Computer System Validation, GxP Regulations
Secondary Skill (Maximum 5 skills can be selected as secondary)
Validation experience with Medical Devices and Infrastructure Qualification
JD (Detailed)
- Experience in validating Medical Devices and Infrastructure Qualification
- 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.
Experience Range
5-8 YrsPrimary Skill (Only 1 skill can be selected as primary)
Computer System Validation, GxP Regulations
Secondary Skill (Maximum 5 skills can be selected as secondary)
Validation experience with Medical Devices and Infrastructure Qualification
JD (Detailed)
- Experience in validating Medical Devices and Infrastructure Qualification
- 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.
Experience Range
5-8 Yrs
