Job Description :
Hi ,



Hope you are doing great!



There is a position for Validation Cum Documentation Engineer-Serialization .



Please show your interest!!





Cognizant is hiring "Validation Cum Documentation Engineer-Serialization for Bridgewater, NJ or Taylor, Pennsylvania location”.



Job Title: Validation cum documentation engineer- Serialization

Job location: Bridgewater, NJ or Taylor, Pennsylvania

Job Duration: Fulltime/Contract



Key skill needed




Validation and Quality documentation experience in pharmaceutical serialization  at level 2 ( Line level) preferably for warehouse operation - using products like Antares WTS, Optel tracksafe, Jekson Retrack or MES, QMS product  ( experience of 6-10 years)
Experience of creation documentation like URS, Tractability matrix, Functional risk assessment, Validation plan, validation report, IQ, SIT, UAT test scripts, User training material creation,business SoP creation
Experience of performing testing - OQ/SIT,UAT




Preferred Skill:




Business process knowledge of Warehouse processes like Receiving, picking, shipping, return etc.
Experience of validating level 3 and 4 serialization - like SAP ATTP, Systech




Job Description:



Validation cum Documentation engineer:



1. Create project validation documentation as per the PUMA methodology ( as listed in the scope of the RFP/Proposal)

2. Ensure document artifacts are reviewed and approved by QA

3. Author IQ/OQ/SIT test cases following standard PUMA test case template and complying quality standards

4.Perform SIT testing ( dry run, QEnv and P Env), report any defects to development team- get fixed and re-test, if required

5. Assist Infrastructure lead/team in performing and documenting IQ/OQ

6. Assist business users in authoring UAT test cases and during executing UAT

7. Assist Infrastructure team in authoring validation plan and validation report

8. Author SoP with support from business users

9. Author User guide/Training material using standard Antares WTS training material

10. Conduct the training to DC business users





Thanks & Regards,

Himanshu Patel

Sr. Technical Recruiter

Tel EXT - 5057

email :




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