Role: Validation Consultant Location: Medina, NY
Job details: - Strong background in validating systems in a FDA regulated environment - Experience with validation of various systems including test script review and approval process . - 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, IQ/OQ and associated test scripts, and Validation Summary Packages ) - Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. - Knowledge of FDA guidance’s and industry standards (i.e., GAMP) - Experience in HP Quality Center and QTP is preferable. - Understanding of the validation requirements and protocols including GAMP, 21 CFR part 11 and GMP - Should have done risk assessments such as 21 CFR Part11, GxP and Detailed risk assessments. - Strong knowledge in GAMP 5 software categorization and identifying the extent of testing as per the category. Thanks and Regards, ____________________ *Karan Tyagi*** *IDC Technologies, Inc*., 1851 McCarthy Boulevard, Suite 116, Milpitas, CA, USA, 95035 Tel: 408-457-9399 Extn: 2067| Fax: 408-608-6088 Email: [email protected] <[email protected]>| Web: www.idctechnologies.com| Yahoo IM: Karan_tyagi2000, Gtalk IM: itrecruiter2012 -- You received this message because you are subscribed to the Google Groups "US_IT_ Jobs" 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/chandrakants?hl=en. For more options, visit https://groups.google.com/groups/opt_out.
