*Job Position:- LIMS – validation* Location: SFO, CA
Duration: 12+ Month Exp.:- 7+ years ================================ *Role: LIMS – validation* *Job Descriptions:* · Develop and author Computer Systems Validation deliverables for regulated applications: Validation Plans, Requirement Specifications, various levels of software testing scripts (IQ, OQ, PQ), Traceability Matrix, and Validation Reports. · Write, review and approve documents to support computerized system processes. · Perform quality review and approval of documents supporting computer system validation processes. · Act as subject matter expert for FDE 21 CFR Part 11 compliance, Part 58, Part 110, Part 211, Part 820 regulations. · Support the validation process of Empower 3 Enterprise application and modules: Method Validation Manager, GPC/SEC, Dissolution, and System Suitability. • Assist manager in reviewing the following types of document: User/Functional Requirements, Technical Design Specifications, validation protocols (IQ, OQ, PQ) and validation final reports. • Created data migration plan, summary and reviewed the data migration documents- Data Preparation Instructions and Post Verification for the MM valuation class change. • Review forms and instrument/LIMS interfaces for data entry into LIMS • Analyze data trending generated by LIMS for process improvement purposes and general QC process improvement • Create Test Plan, Test Summary report, Transport reports, reviewed Test Scripts in QC for Regular M&E cycles. • Responsible for coordinating, locating, tracking, organizing, and verifying validation documentation for cGMP compliance and regulatory requirements. • Review the User Requirement and prepare the detailed Test Plans and Test Criteria. • Develop, review and execute Test Plans, Test Cases and Test Conditions. • Involve in designing and writing training manual templates and project planning. · Experienced in FDA regulations and industry guidance documents including cGxP, 21 CFR Part 11, ANNEX 11, GAMP 4 and 5 and Software Development Life Cycle models. · Strong experience in development of Validation Protocols like Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for the related applications =================================== *In case you are not looking for the change at this point of time please refer your colleagues, Friends etc.* *Regards,* *Deepak Kaushik* *IDC Technologies, Inc.* d...@idctechnologies.com 408-418-5778 ext-3041 Gtalk:deep.cit71 YIM:deepak_cit22 https://www.linkedin.com/in/deepak-kumar-80b38055 -- You received this message because you are subscribed to the Google Groups "SAP Resource Center" group. To unsubscribe from this group and stop receiving emails from it, send an email to sap-resource-center+unsubscr...@googlegroups.com. To post to this group, send email to sap-resource-center@googlegroups.com. Visit this group at https://groups.google.com/group/sap-resource-center. For more options, visit https://groups.google.com/d/optout.
