*Urgent fill for direct client- Sr CAPA - Quality Assurance
Analyst,Malvern, PA*

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*Title -                  Sr CAPA – Quality Assurance Analyst*

*Location:            Malvern, PA*

*Start-                  ASAP*

*Duration:           2 Years  *

*Rate: on Corp-Corp or 1099 only.***

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*Candidate will have to undergo a through drug and background test upon
selection*

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CAPA Consultant

A Healthcare Quality/Technology organization has just completed an audit on
the H IT CAPA process. The audit produced a number of findings and
remediation items that require new process implementation. The individual
will be responsible for development and implementation of the H IT CAPA
process and tools in accordance with ISO 9001:2008 and FDA QSR 820.100. The
resource has to be an expert on Section 820.100 for the CAPA process. The
resource needs to be well versed in quality management process and have
experience in ISO 9001.

Skillsets:
• Design of CAPA process
• Implementation of CAPA process
• Selection and implementation of CAPA Tools
• ISO 9001:2008 – Section 8
• FDA QSR 820
• GHTF SG3 CAPA****

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