Pharma CSV Validation Specialist

Katalyst-Healthcares-; Little Rock (AR); On-site; USD 80,000 - 110,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a candidate with strong background in pharmaceutical validation and GMP/GxP knowledge to lead computer system validation efforts. Ex-Pharmaceutical experience is preferred and you will coordinate validation activities across QA, IT, and project teams.

You will write and review validation deliverables, test plans, protocols, and traceability matrices, while ensuring compliance with FDA guidance and GAMP standards in a fast-paced environment.

Qualifications

• 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 (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.

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.

Skills

Pharma industry knowledge

GxP compliance

Documentation writing

Team leadership

Communication skills

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.