Analyst - Quality Operations

Job Description Summary

-Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.

Job Description

Major accountabilities:

1. Handling of Audit CAPA actions, Deviations and Investigations.

2. Preparation of annual audit plans

3. Monitoring and maintain of KQIs and KPIs.2.

4. Maintenace of Shrepoints and Repositories.

5. Responsible to update the information on SharePoint/ trackers, review the applicable documents for correctness and archival of necessary documents on SharePoint.

6. Provide Administrative support in preparation of Quality Management Review meeting slide deck & metrics reporting.

7. Preparation, approval, and management of QAAs.

8. Develop and maintain process SOPs, working procedures and process maps.

9. Provide support for GMP External Audits and inspection management activities (HA and Self Inspection Audits).

10. Maintain Approved supplier list for GxP vendors.

11. Preparation of UQAP (Unified Quality Audit Program), Audit preparation support and QARP (Quality assurance responsible Person) Role for audit CAPA Management.

Minimum Requirements:

M.Pharm/ equivalent from a reputed institute.

Min 4-6 yr Experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances or products/ Medical device.

Basic awareness of GxP compliance requirements.

Work Experience:

• QMS Knowledge w.r.t. deviations, Investigations, handling of CAPA.
  

Skills Desired

Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence