CSV Consultant

JobDiva, Inc.; Fayetteville (AR); On-site; USD 70,000 - 110,000; Full time

Job summary

JobDiva, Inc. is seeking a qualified professional with extensive experience in the pharmaceutical, biotech, or medical device industries to lead validation efforts.

The role requires 2+ years in the System Development Lifecycle and 3+ years in Computer System Validation, with strong knowledge of FDA guidance and GxP standards. Candidates should be adept at drafting and reviewing validation deliverables, from requirements through validation reports, and collaborating with remote teams on multiple

Qualifications

• Experience in pharmaceutical, biotech, or medical device industries.
• Knowledge of FDA guidance and GAMP.
• Experience in writing and executing validation deliverables (requirements, validation plans, test protocols, test reports).
• Experience with QA methodologies, test plans, and UAT/test scripts.

Responsibilities

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

Skills

Pharma industry

GxP knowledge

FDA guidance

Validation documentation

Team collaboration

Risk-based validation

Computer System Validation

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.