DM/ Manager - Global Quality Audits & Compliance - QMS Expert

SV MANAGEMENT CONSULTANTS
  • Hyderabad
  • Confidential
  • 10-12 years
  • 308 Views
  • 19 May 2015
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  • Quality Control - Product/ Process, Audit and Assurance

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Role:

Prepare & review the global Audit Plan for all internal and external sites;
Plan and perform audits as per the audit schedule, compile final audit report after collating the same from different team members and share with the site-teams.
Ensure the compliance to the regulatory audit observations;
Ensure the compliance to internal standards;
Conduct follow-up audits to ensure compliance of audit observations, in order to adhere to the schedule, and to ensure anytime audit readiness.
To perform pre-audits prior to regulatory audit. Support the unit teams / QA teams in regulatory audits with facilities & documentation based on the need in order to ensure smooth handling of external audits.
Perform analysis on audit observations and to share summary to the Head Audit and Compliance to draw conclusions on training needs. The learning to be shared across the internal sites in order to build unit/business level capability in terms of compliance & audit preparedness.


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SV MANAGEMENT CONSULTANTS