Job Position:- LIMS – validation
Location: SFO, CA
Duration: 12+ Month
Exp.:- 7+ years
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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
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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.
408-418-5778 ext-3041
Gtalk:deep.cit71
YIM:deepak_cit22
https://www.linkedin.com/in/deepak-kumar-80b38055
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