*Please send the resume to [email protected]
<[email protected]> *

*Dear Partner,*

*Alliedinformatics is a highly recognized provider of professional IT
Consulting services in the US.*


*Here is our open requirement which can be filled immediately. Kindly
respond to this requirement with your consultant resume, contact and
current location info to speed up the interview process.*

Position :- QA with Validation

Location :- Vernon Hills, Illinois or Westlake Village CA

Duration :- 12 months







Qualifications

•  5 - 7 years’ experience in Pharma Quality & Compliance.

• Experience in FDA regulated environment with good understanding of cGxP
(cGMP, cGDP, cGAMP, cGLP) standards.

• Experience in Computer system validation and knowledge of GAMP 5

• Experience in writing and executing documentation for all aspects of the
validation deliverables (etc. Requirements, Compliance/validation Plans,
test protocols, Test Summary reports and Compliance/validation reports.

• Experience in reviewing system test and user acceptance test scripts,
Traceability matrix and Design Specs.

• Experience in Software Development Lifecycle (SDLC).

• Experience in QA Methodologies, designing, reviewing and approving Test
Plans, systems and UAT test scripts and Test procedures.

• Experience in Change Control.

• Experience on various FDA standards (21 CFR Part 11, 210, 211, 820)

• Experience is creation of SOPs.

• Knowledge of FDA guidance’s and industry standards (i.e., GAMP5)

• Hands on experience in HP Quality Center and QTP.

• Strong verbal and written communication skills.

• Able to work as a team player, lead a team or accomplish tasks without
supervision.

• Ability to work with remote teams and support several changes/projects
simultaneously.

• Flexibility to work with an onshore/offshore model.


Thanks & regards
Moiz Khan

Allied Informatics Inc.

1815 Satellite Blvd. Suite 302

Duluth, GA 30097 USA.
Ph: 770-246-9800 x117 Fax No. 770-246-9098
Email: [email protected] <[email protected]>  URL:
www.alliedinformatics.com

YM :- moizkhan_recruiter  Gtalk :-  recruiterkhan.it

http://in.linkedin.com/pub/moiz-khan/29/952/1a6



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