CSV Consultant

Katalyst CRO; Little Rock (AR); In loco; USD 65.000 - 90.000; Tempo pieno

Descrizione del lavoro

Katalyst CRO is seeking a qualified professional with strong experience in pharmaceutical validation and CSVD lifecycle to lead and support validation activities. You will work with cross-functional teams to create, execute, and document validation deliverables in a regulated environment.

Candidates should have extensive knowledge of FDA/GxP guidelines, QA methodologies, and the ability to review tests, traceability, and design specs while coordinating with remote teams on multiple projects.

Competenze

• Experience in the Pharmaceutical, biotechnology, or medical device industry.
• 2+ years' experience with System Development Lifecyle.
• 3+ years' experience in Computer System Validation.
• 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.

Mansioni

• Collaborate with cross-functional teams on validation deliverables.
• Develop and execute validation plans, test protocols, and summary reports.
• Review system tests, UAT scripts, traceability matrices, and design specs.
• Ensure QA methodologies are applied across projects and maintain clear communication.

Conoscenze

Pharma/biotech/medical device industry

System Development Life Cycle

Computer System Validation

FDA/GxP regulations

FDA guidance & GAMP

Validation documentation

QA methodologies & test plans

Communication skills

Descrizione del lavoro

• 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.