* 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. * Strong verbal, written and presentation skills.
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