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Quality Assurance - Senior executive - Market compliants

0 years

0 Lacs

Dehradun Uttarakhand India

Posted:2 months ago| Platform: Linkedin logo

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Skills Required

compliance analysis risk stability reports data

Work Mode

On-site

Job Type

Full Time

Job Description


  • Evaluate market complaint and initiate investigation. Identification of route cause (RCA).
  • Investigate & Review OOS/OOT/CAPA .
  • Review and ensure compliance for CAPA for both internal and external audits.
  • To issue deviation & ensure, CAPA & RCA analysis for deviation.
  • To provide RPN Numbers to Risk & plan CAPA as per RPN numbers as per SOP.
  • Periodic Post Approval Review of Vendors (RM & PM)
  • Issuance of STOP Sale Letters based on Stability Reports or Market Complaints
  • Perform periodic mock recall inline with SOP
  • Issuance of Response of Market Complaint to regulators / complainant
  • Review of Fninished Product Specifications
  • Compilation of Data for Skip Testing

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