Hi Folks,
Please find the below demand. Please submit qualified candidates asap
Client - Cognizant
Need Passport number for submission
Please share resume at Varun.j@net2source (DOT) com
*Position : Computer System Validation Analyst/Engineer*
*Location : Chicago, IL/ Remote*
*Job Description :*
Domain skill- Pharmaceuticals/Biotech or Regulatory Mirror
- LIMS or MES or QMS in regulatory industries
- Experience in drafting and/or reviewing computer validation deliverables
such as Validation Plan Requirements Specifications Risk assessments IQ OQ
PQ/UAT
- Configuration and Design Specification Traceability Matrix Migration Plan
and Summary Reports.
- Reviews and assists System and Business owner to draft software user
specifications and regulatory requirements.
- Executes validation and qualification protocols test scripts and summary
reports per applicable SOP’s and assures that acceptance criteria related
to validation and qualification protocols are met.
- Assist in the creation of training materials such as work instructions
admin guides and user manuals.
- Assist in developing validation and testing strategies for computer
system projects.
- Perform or support system testing test script execution (internal or
vendor-provided) test error documentation and resolution and test script
documentation and archiving.
- Experience in change management process including performing impact
assessments to determine impact of changes to the Validation Status using
appropriate change control procedures.
- Experience in drafting and/or reviewing validation and change control
protocols documents and reports.
- Review and remediate executed test scripts for GDP errors and omissions.
- Experience in drafting and/or reviewing testing exception reports.
*Qualifications and Minimum Requirements *
1. 5 + years IT Quality / Validation experience in computerized system
validation within a regulated environment.
2. Knowledge of GxP and ERES (21CFR Part 11 and Annex 11) regulations
and guidelines
3. Working knowledge of the IT system development life cycle and
software quality assurance in a regulated environment.
4. Knowledge of IT methodologies including GAMPS and ITIL Experience
with risk analysis and risk management practices and tools.
5. Good communication skills both verbal and written
6. 6. Knowledge of general software database concepts and data integrity
knowledge of infrastructure technology and platforms.
7. The ability to work both independently and with teams
8. Experience with LabVantage LIMS/MES or Veeva QMS is preferred
9. Experience with the below systems is preferred:
a. Document management software (Veeva QualityDocs etc.)
b. IT change management software (ServiceNow etc.)
c. Learning Management software (ComplianceWire etc.)
d. Regulatory Information Management System (Veeva RIMS etc.)
e. Inventory Management System f. Manufacturing Execution System
10. Bachelor’s Degree in information technology Computer Science and/or
any other closely related field is highly preferred.
Regards,
*Varun Jain*
*Senior Recruiter*
*Net2Source Inc.*
*Email: *Varun.j (@) net2source.com <varu...@net2source.com>
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