Immediate hire: Senior Tester - Irvine , CA

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)


Remarks

Risk Assessment


 

21 CFR Part 11, 21 CFR Part 820


 

GxP regulations


 

Good Documentation Practices


 

Document Version Control Tools

 

 


 




Desired Skills

Technical / Soft Skills

Expertise Level (Expert / Good / Knowledge)


Remarks

Quality Center

 

 

Basic Laboratory Equipment Usage 

 

 

FMEA

 

 

 

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

--
You received this message because you are subscribed to the Google Groups "Entry level IT Jobs in US + H1B visa sponsor" group.
To unsubscribe from this group and stop receiving emails from it, send an email to entry-level-it-jobs-in-us-h1b-visa-sponsor+unsubscribe@googlegroups.com.
To post to this group, send email to entry-level-it-jobs-in-us-h1b-visa-sponsor@googlegroups.com.
Visit this group at http://groups.google.com/group/entry-level-it-jobs-in-us-h1b-visa-sponsor.
For more options, visit https://groups.google.com/d/optout.

0 comments:

Post a Comment

 
College & Education © 2012 | Designed by