*Please forward your resumes at [email protected]*
*Title Quality & Compliance Lead (FDA, cGxP, 21 CFR Part)* *Location: East Hanover NJ Duration 6 months Contract* * * *Job description:* § 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. § 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 (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. § Flexibility to work with an onshore/offshore model. Knowledge working with systems; such as, SAP, Red Prairie and data management *Poonam Sharma* Sr. Manager - Recruitment *Net**2**Source Inc.,* *MBE Certified - NMSDC* *SBE Certified (State of NJ)* Board: (201) 340 8700 Ext.: 419| Fax: (201) 221-8131 Email: [email protected] -- You received this message because you are subscribed to the Google Groups "SAP ABAP" group. To post to this group, send email to [email protected]. To unsubscribe from this group, send email to [email protected]. For more options, visit this group at http://groups.google.com/group/sap-abap?hl=en.
