Dy. Manager/ Manager - Audit & Compliance - QC Expert

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

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Role:


Internal Audits : Perform audits across multiple sites, prepare audit reports and conduct follow-ups to ensure anytime audit readiness of QC Lab
Mock Audits : Perform cause-based audits with documentation, follow-up for closure of corrective and preventive actions (CAPA) to ensure preparation for external audits
Vendor Audit Support : Perform external manufacturing sites and vendor audits in order to ensure cGMP compliance
Critical System Reviews : To conduct critical system reviews to assess the gaps and to propose the correction plan to harmonization.
Regulatory Compliance Verifications : Verify the regulatory audit responses across sites and their level of implementation. Guide the teams to take appropriate actions

Desired Profile

Technical Requirements: Well versed with cGMP& regulatory guidelines and basic knowledge of Quality Control Lab.

Key Personal Attributes

- Good communication skills, highly energetic and good influencing ability
- Business and commercial orientation
- Excellent interpersonal skills



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SV MANAGEMENT CONSULTANTS