Job Description • The validation analyst will provide an advisory role as needed. This may include: o Advising clients on assigning proper risk to computer systems o Advising clients on how to meet compliance requirements. o Advising clients on developing test that provide adequate compliance coverage as well as thoroughly tests business requirements. • Work with client to develop validation plan to ensure that, at the end of the project, the system meets FDA compliance requirements. • Work with client business functions and subject matter experts to develop User Requirements, Functional, and Design Specifications to establish hardware/software requirements • Develop test / validation scripts based on software / hardware design / configuration • Develop Installation tests / qualifications scripts based on Design • Develop Operation tests / qualifications scripts based on functional requirements • Develop Performance tests / qualification scripts based on configuration • Interact in a team environment, managing tasks and escalating issues as needed.
Education & Experience/Technical Competencies: • University certificate or degree with a minimum of 5 years of related industry exp, or BS in Technology & 2-3 years of exp. • Minimum 3 to 5 years in pharmaceutical industry, focusing on Systems Validation. • Thorough understanding of the principles of GAMP, SDLC methodologies and testing best practice. • Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems. • Expertise in use and validation of GMP systems.
Job Knowledge/Skillsets: • Fluent knowledge of rules and regulations: GAMP 5, CFR Part 11 Compliance and CFR Part 210, 211 Compliance. • Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project) • Ability to work independently. • Strong organizational/ facilitation/communication skills.