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Compliance Manager
Compliance Manager

Compliance Manager

Posted On : 2019-01-10

Ref.No : PHI/WIP/228

No.of Openings: 1

Work Permit : Available

Designation :Compliance Manager

Industries :IT/ Computers - Software

Expiry Date :2019-02-16

Skills : Non- SAP   /  Compliance Management

Total Experience : 8 to 9 Year

Relevant Experience : 7 to 8 Year

Job Type : Contract

Job Location : Manyata Tech Park

Notice Period : 20 to 30 Days

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Job Description

Skills : Medical Devices CSV - Computerized System Validation

7+ yrs expertise in validation of enterprise-wide Quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines.

Strong background in FDA, ISO and EU regulations for medical devices and healthcare especially FDA 21CFR Part 820/Part 11, ISO 13485 and EU Annex 1.    

Actively participate in the Validation Life Cycle of regulated IT projects by evaluating validation documentation,  Provide guidance/feedback to IT project teams in Validation compliance as per the applicable regulatory requirements and  customer  Healthcare policies and procedures.   

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