CSV Consultant

Katalyst-Healthcares-; Little Rock (AR); On-site; USD 90,000 - 140,000; Full time

Job summary

Katalyst-Healthcares- is seeking a validation-focused professional with background in pharmaceutical, biotechnology, or medical device industries. The role emphasizes experience with System Development Lifecycle and computer system validation in regulated environments.

Candidates with FDA/GxP knowledge and ability to manage documentation, risk-based validation, and QA methodologies will excel. Remote collaboration across teams and multiple projects is expected.

Responsibilities

• Ex-Pharmaceutical preferred.
• Experience in Pharmaceutical, biotechnology, or medical device industry.
• 2+ years' experience with System Development Lifecycle.
• 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 (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.

Job description

Roles & Responsibilities:

• Ex-Pharmaceutical preferred.
• 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.