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Rate –$63 per hour
Job location - Piscataway, NJ
No. of positions – 3
Duration – 8 months, 6 month, 3 month)
Mandatory skills – FDA compliance and QA review
Compliance Lead Job Description: 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. Qualifications ?5- 7 years experience in Quality & Compliance with
a Bachelors degree.
1.Experience in FDA regulated environment with good understanding of cGxP
(cGMP, cGDP, cGAMP, cGLP) standards and Risk based validation.
2.Experience in Computer system validation.
3.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.
4.Experience in reviewing system test and user acceptance test scripts,
Traceability matrix and Design Specs.
5.Experience in Software Development Lifecycle (SDLC).
6.Experience in QA Methodologies, designing, reviewing and approving Test
Plans, systems and UAT test scripts and Test procedures.
7.Experience in Change Control.
8.Experience on various FDA standards (21 CFR Part 11, 210, 211, 820)
9.Experience is creation of SOPs. 1
10.Knowledge of FDA guidance?s and industry standards (i.e., GAMP)
11.Hands on experience in HP Quality Center and QTP.
12.Strong verbal and written communication skills.
13.Able to work as a team player, lead a team or accomplish tasks without
14.Ability to work with remote teams and support several changes/projects
15.Flexibility to work with an onshore/offshore model.
16.Knowledge working with systems; such as, SAP, Red Prairie and data
*Business Integra Inc*
Resources to be your own W2 or H1 Transfer (Receipt copy to be sent within
30 days after joining). Business Integra reserves the right to work with
consultant's original employer and provide no finders fee or any other
payment for submitting non W2 consultants for any of our requirements
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