*PLEASE REVERT BACK :: nit...@idctechnologies.com
<nit...@idctechnologies.com>*

*Role*: Compliance lead

*Location*: Waukegan, IL

*Type*: Long term contract



*Description:*

·         Experience in conducting Regulatory Applicability and Regulatory
Risk assessments of systems in accordance with GAMP

·         Extensive knowledge of all the stages of the System Development
Life Cycle (SDLC) and conducting reviews of all systems lifecycle
deliverables

·         Ability to develop Validation strategies, Quality
Assurance/Validation plans, Quality/Validation Assurance Summary Reports to
install different systems that fall under GxP or non-GxP categories

·         Understanding of Regulatory requirements of systems and approval
requirements

·         Understanding of 21 CFR part 11 requirements

·         Knowledge in conducting Supplier/Vendor assessments

·         Ability to perform Information Security risk assessments

·         Experience in audit support and CAPA plan preparation and
implementation




*Thanks & Regards*

*Nitesh Pandey*



*IDC Technologies | 1851 McCarthy Blvd. Suite 116, Milpitas, CA 95035*

Email: *nit...@idctechnologies.com* <nit...@idctechnologies.com>* | Direct:
408-418-5779 ext 1040*

*Yahoo: nitesh.iilm*

*ISO 9001-2008 Certified*



*| **www.idctechnologies.com* <http://www.idctechnologies.com/>



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