Hi,
Please go through the requirement below and let me know your interest:
Title – Senior Tester
Location - Irvine, California
Duration: 6+ months
Embedded product testing, computer system validation in addition to 21CFR part 11
Experience: Minimum 3 years
• Experience in validating the Laboratory Equipment, Computerized System and Manufacturing Equipment.
• Should have system verification knowledge.
· Extensive validation experience in 21 CFR Part 11.
• Good understanding of GxP standards.
• Well acquainted with all the phases of Validation Life Cycle (VLC).
• Expertise in planning and execution of Validation Master Plan, requirements gathering (User Requirement Specifications).
• Extensive experience in creating, reviewing and executing test protocols (Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)), Traceability Matrix and Validation Summary Report (VSR).
• Expertise in technical writing and reviewing of Standard Operating Procedures (SOPs), Work Instructions.
• Excellent knowledge and good working experience in executing Gap Analysis, and Change Control Process.
• Extensive experience in performing Risk Assessment and Failure Modes and Effects Analysis (FMEA).
• Extensive experience with testing tools like HP Quality Center
· Good communication skills and English fluency.
Additional Requirement:
Good expertise in developing the following validation deliverables – Risk Assessments,
Regulatory Assessments, 21 CFR Part 11 Assessments, Gap Analysis documents, Validation Plans, Qualification Protocols, Validation reports, IQ/OQ/PQ test scripts, Deviation/Incident Reports, Change Controls and Problem Reports.
PS: Please share the profile with Educational Qualification as "Engineering" in EEE, EIE, ECE, Bio-Engineering, etc with all other mandatory skill set required for Computerized System Validation as.
| Technical / Soft Skills | Expertise Level (Expert / Good / Knowledge) |
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| Risk Assessment |
| |
| 21 CFR Part 11, 21 CFR Part 820 |
| |
| GxP regulations |
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| Good Documentation Practices |
| |
| Document Version Control Tools |
|
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| Desired Skills | ||
| Technical / Soft Skills | Expertise Level (Expert / Good / Knowledge) |
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| Quality Center |
|
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| Basic Laboratory Equipment Usage |
|
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| FMEA |
|
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Deeksha Marwaha
Technical Recruiter
Technology Resource Group Inc.
Email: deeksha@tresourceinc.com
Direct- 408-852-1252
|Desk - 408-709-1760 Ext. 951| |Fax: 408-884-2409|
3736 Hills-dale Court, Santa Clara, CA 95051
Gtalk : diyamarwaha24@gmail.com
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