*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 "Open Source Erp & Crm" group. To unsubscribe from this group and stop receiving emails from it, send an email to open-source-erp-crm+unsubscr...@googlegroups.com. To post to this group, send email to open-source-erp-crm@googlegroups.com. Visit this group at https://groups.google.com/group/open-source-erp-crm. For more options, visit https://groups.google.com/d/optout.
