Hi ,

   Hope you are doing great.

 This is Kishore from Ikcon Technologies, we have an urgent requirement on 
QA Validation at Warren, NJ. Please let me know if you are interested for 
this position. You will reach me at *kish...@ikcontech.com*

Title: QA Validation
Duration: 6 mon
Location: Warren, NJ
Interview: Telephonic + In-Person.
 
JD:
Results-driven pharmaceutical validation professional with extensive 
experience in FDA regulated environment. Effective oral and written 
communication skills; works well independently and/or in cross-functional 
teams. Expertise includes:
• Analytical instruments and equipment qualification.
• Software validation (21 CFR Part 11, EU Annex 11, GAMP 5).
• cGMP (21 CFR Part 210 and 211) and Quality Systems (21 CFR Part 820).
• Validation deliverables (URS, FS, CS, TM, IQ/OQ/PQ protocols, validation 
plans, 
summary reports).
• Temperature mapping using TempTales and Kaye Validator.
• Technical assessment, validation risk and gap analysis.
• Project management (execution, scheduling, vendors/stakeholders 
management, reporting, closing).
• Change control and CAPA (TrackWise, QTS).
• MS Office Suite (Word, Excel, Access, PowerPoint, Visio, Project) or 
equivalent (OpenOffice, LibreOffice).
• Enterprise content management (PDOCs, GXPharma, EDMS).
• Lean Six Sigma quality tools, statistical methods and software (Minitab).

*[image: 1482179204748_ik.jpg]*

*Best Regards,*

*Kishore.*

*IKCON Technologies Inc*

*Office : 848-206-0010*

*Email: kish...@ikcontech.com*

http://www.ikcontech.com/

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