Hi, This is Vivek from Deegit Inc. We have the following position open with one of our direct clients. Please let me know your interest by responding to *[email protected] <[email protected]>*. Thanks!!
*Role:* CSV / TMV Validation with Medical Devices *Location:* Lake Forest, CA *Duration:* 6+ Months *Job Description:* · 5 years’ experience in CSV / TMV Validation with with Medical Devices · Gap analysis for Design History File procedures as per quality system policies and procedures, FDA and international requirements, and ISO Standards for Medical Devices · Experience in FDA regulated environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards. · Experience in Computer system validation and knowledge of GAMP 5 · 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., GAMP5) · Hands on experience in HP Quality Center and QTP. · Strong verbal and written communication skills. -- *Best Regards,* *Vivek * [email protected] GTalk: [email protected] Skype: vivekbhargav1299 -- You received this message because you are subscribed to the Google Groups "International SAP Projects" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/international-sap-projects. For more options, visit https://groups.google.com/d/optout.
