Computer System Validation(Trackwise/FDA/Implementation) Consultant

Job type:
Start date:
1 week
6 months
DG Business Solutions Inc
Published at:
flag_no USA
Project ID:

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We are looking for a Computer System Validation Consultant (Trackwise configuration/FDA/Implementation) in CA

Job Location: Foster City, CA

Number of positions: 1

Duration: 6 months

Trackwise configuration, implementation,URS/FRS writing

Experience in 2-3 implementations.

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 (ie, 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

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.