CSV Consultant
Katalyst Talent Agency
Denver, CO, United States
11 days ago
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Role details
Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Experienced
Experience required
2 years minimum
Compensation
$34,237.0 - $40,414.0
Working hours
Regular working hours
Job source
Tech stack
Systems Development Life Cycle
System Testing
GXP
Job description
Seeking experienced professionals who want greater ownership, flexibility, autonomy, and purpose in their careers. Build your own recruiting business with the support of an estab…
- 7 days ago +
Requirements
- Experience in the Pharmaceutical, biotechnology, or medical device industry.
- 2+ years’ experience with System Development Lifecyle.
- 3+ 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.
- Knowledge of FDA guidance’s and industry standards (i.e., GAMP).
- 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. 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.
About the company
Aramco energizes the world economy. Aramco occupies a special position in the global energy industry. We are one of the world’s largest producers of hydrocarbon energy and chemic…
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