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Regulatory Compliance and Laboratory Systems
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We provide a wide selection of skilled consultants for our FDA Regulated clients. These skill-sets may involve the following types of positions:
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Software Quality Compliance Analysts |
LIMS Support |
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Software Validation Specialists |
IT Auditors |
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Quality Assurance Specialists |
LIMS Design / Configuration |
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Laboratory Systems Specialists |
LIMS Basic Programming |
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Equipment Validation Specialists |
Crystal Reports |
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Technical Documentation Writers |
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The consultants we provide can vary in skill sets and function, as well as, required experience. For our Junior Level positions, the minimum requirement is 3+ years of technical experience. For our Senior Level positions, we require 8 to 15+ years of technical experience.
- Total IM Compliance Support
- Remediation / Validation
- IQ / OQ for Software & Equipment
- Change Control Requests
- Gap Assessment Report
- System Application Forms (SAF)
- Change Control Request (CCR)
- Project Planning Form (PPF)
- Validation Strategy Documents (VSD)
- Software Contractor Qualification (SCQ)
- Requirements Specifications (URS, PRS and SRS)
- Validation Protocols
- Traceability Matrix
- Standard Operating Procedures
- Training Materials
- Project Management
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One or more of the following skills may be required in any of our positions:
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Validation Plans |
Validation Reports |
IQ, OQ, PQ |
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Gap Analysis |
Audits |
GxP Regulations |
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Test Protocols |
Requirements Specs |
cGMP |
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Risk Analysis |
Processes / Procedures |
GAMP4 |
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21 CFR Part 11 |
QSR Regulations |
SOP's, etc. |
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Unlike other companies who spread themselves too thin (by trying to do everything for everyone), our goal is to be your company of choice for all your Regulatory Compliance and Laboratory Systems consulting needs.
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Phone: (786)
268-1944 / Fax: (786) 268-1945
Luna Source, Inc.
1031 Ives Dairy Road Suite 228
Miami, FL 33179 E-mail: recruiting@lunasource.com
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Copyright © 2011 Luna Source, Inc
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