Hello Partners, **
*Send the profiles with rate confirmation to process immediately.* Please send suitable resume to *sivakumar.radhakrish...@businessintegra.com*<sivakumar.radhakrish...@businessintegra.com> ** * * 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 JD: 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 supervision. 14.Ability to work with remote teams and support several changes/projects simultaneously. 15.Flexibility to work with an onshore/offshore model. 16.Knowledge working with systems; such as, SAP, Red Prairie and data management systems) *Regards,*** *Siva* *Business Integra Inc* *Direct: 602-710-4135* *Fax: 301-474-9651* *Email: **sivakumar.radhakrish...@businessintegra.com*<sivakumar.radhakrish...@businessintegra.com> 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 -- You received this message because you are subscribed to the Google Groups "REQSRESUMES" group. To post to this group, send email to firstname.lastname@example.org. To unsubscribe from this group, send email to reqsresumes+unsubscr...@googlegroups.com. For more options, visit this group at http://groups.google.com/group/reqsresumes?hl=en.