Innovations technological

Title: Validation Tester with Maximo

Location: Foster City, CA

Duration:  6+ Months

Positions: 1

Note: Client needs Work Authorization Copy at the time of submission only

Job Description:

·         7+ years experience in Quality & Compliance with a Bachelors degree.

·         Experience in FDA regulated environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk based validation.

·         Experience in Computer system validation.

·         Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.

·         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 Software Development Lifecycle (SDLC).

·         Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.

·         Experience in Change Control.

·         Experience on various FDA standards (21 CFR Part 11, 210, 211, 820)

·         Experience is creation of SOPs.

·         Knowledge of FDA guidance's and industry standards (i.e., GAMP)

·         Hands on experience in HP Quality Center and QTP.

·         Strong verbal and written communication skills.

·         Able 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.

·         Flexibility to work with an onshore/offshore model.

·         Participate in the development of strategic compliance deliverables to support applicable regulations and internal policies

·         and to ensure systems to be developed adhere to corporate SDLC methodology.

·         Drive understanding and adoption of Quality and Compliance standards.

·         Ensure Quality & Compliance requirements are considered in any initiative or major change request. 

·         Ensure the compliance deliverables are updated and kept current with all applicable changes.