Hi,
Please find the below requirement and let me know your consultant comfort levels. Please send matching profiles to Jyothi@sun-itsolutions.com.
Location: Piscataway New Jersey
Duration:6months+
Job Description:
1. 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.
2. Drive understanding and adoption of Quality and Compliance standards.
3. Ensure Quality & Compliance requirements are considered in every step of the project including test script creation, review, test execution and Post execution documentation/reports.
4. Ensure the compliance deliverables are updated and kept current with all applicable changes.
5. Work with IT and business teams within Customer teams to drive/maintain/create Quality program.
6. Align the Test methodology with Compliance plans, policies and procedures. Effectively manage ongoing testing & change control process (interface to IT support, impact analysis, release mgt, data changes, testing etc.).
7. Build strong relationships with franchise quality business owners.
Required: Authorization/Eligibility to work in Piscataway New Jersey starting from March 31st 2014.
Qualifications
A. Must have working experience as Compliance Pharma Validation consultant systems; for SAP, Supply chain related modules or any other ERP.
B. 5- 7 years experience in Quality & Compliance with a Bachelors degree.
C. Experience in FDA regulated environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk based validation.
D. Experience in Computer system validation.
E. 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.
F. Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.
G. Experience in Software Development Lifecycle (SDLC).
H. Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
I. Experience in Change Control.
J. Experience on various FDA standards (21 CFR Part 11, 210, 211, 820)
K. Experience is creation of SOPs.
L. Knowledge of FDA guidance’s and industry standards (i.e., GAMP)
M. Hands on experience in HP Quality Center and QTP.
N. Strong verbal and written communication skills.
O. Able to work as a team player, lead a team or accomplish tasks without supervision.
P. Ability to work with remote teams and support several changes/projects simultaneously.
Q. Flexibility to work with an onshore/offshore model.
Jyothi
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