We have this Urgent direct client requirement.Please find the details and send your resume ASAP!
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. Work with IT and business teams within HCS/CLS to drive/maintain/create Quality program. Aligns the development methodology with Compliance plans, policies and procedures. Effectively manage ongoing change control process (interface to IT support, impact analysis, release mgt, data changes, testing etc.). Build strong relationships with franchise quality business owners. Self driven individual with the ability to work in Memphis for the duration of the project, reporting to New Jersey management.
? 5- 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 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 Software Development Lifecycle (SDLC).
? Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
? Completed a compliance project deployment from conception to implementation.
? Experience Managing projects.
? 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.
? Knowledge working with temperature sensors
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