Sr. Officer/Executive Corporate Quality & Compliance | Sun Pharma | Vadodara

Manufacturing, QA/QC/QMS/IPQA/CQA
Gujarat
March 11, 2023
Full Time
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Job Overview

  • Date Posted
    March 11, 2023
  • Location (State / UT)
    Gujarat
  • Expiration date
    --
  • Experience
    4 Years, 5 Years
  • Gender
    Any
  • Desired Qualification
    Master’s Degree, Bachelor Degree

Job Description

Roles and Responsibilities

  • Registration of Market Complaints in Track wise system & its Classification but not limited to; Process and analyzing product complaints according to Global standards. Evaluation of each complaint for seriousness, correctness, and consistency of defect categorization.
  • Acknowledge the complaints to the complainant (as applicable) and assist the manufacturing site in the investigation.
  • Follow-up with the complainant for Complaint samples, and additional information required to support product complaint investigation.
  • Tracking of complaint samples & sending it to the site for investigation
  • Coordinate with another stakeholder (PVG, Distribution, RA, Business, Legal, etc.) involved in the complaint-handling process.
  • Review of investigations and ensure corrective and preventive actions are in place. Drafting and sharing the responses to the complainant.
  • Monthly/ Quarterly Trending of product quality complaints and discussion with sites for actionable.
  • Update Global Tracker of Complaint, FAR & Recall and provide the information to relevant stakeholders ad-hoc basis.
  • Review the ProPharma database for US complaints specifically for potential FAR candidates and escalate to responsible personnel to assess FAR applicability.
  • Monitor the recall process. Verify the reconciliation of recall quantity against the destruction certificate of the recalled stock.
  • Assist in Track wise troubleshooting for recall and PQC module.
  • Work as a member of a team to achieve all outcomes.
  • Perform all work considering the quality themes i.e. drive for growth, innovation & continuous improvement, value creation, and excellence in execution, and demonstrate strong and visible support of our values.
  • Perform all work in accordance with all established regulatory compliance and safety requirements.
  • All other duties as assigned by the reporting manager in accordance with the established responsibilities and compliance requirements.

Qualification:  B.Pharma, M.Pharma

Experience: 4-5 years

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