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 "CorptoCorp" 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/corptocorp. For more options, visit https://groups.google.com/d/optout.
