Market Complaints – Assistant Manager | Glenmark Pharma | Mumbai

Manufacturing, Microbiology, Production, QA/QC/QMS/IPQA/CQA
Maharashtra
January 25, 2023
Full Time
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Job Overview

  • Date Posted
    January 25, 2023
  • Location (State / UT)
    Maharashtra
  • Expiration date
    --
  • Experience
    12 Years, 15 Years
  • Gender
    Any
  • Desired Qualification
    Master’s Degree

Job Description

Roles and Responsibilities

  • Responsible for Handling Product Quality Complaints (PQCs) for Formulations coordination with manufacturing sites, investigation & Compliance team (I & C) / Quality department for receiving, assessment, evaluating, holistic Investigation, finding out root causes, taking adequate corrective actions and implementing robust Preventive measures to minimize or avoid future complaints from the market.
  • Monitoring the lifecycle management of market complaints right from preliminary assessment, Investigations, responses, CAPA implementations, and closing of Product Quality Complaints related to Domestic & ROW complaints.
  • Forwarding Product Quality Complaints (PQC) to appropriate Contact Quality persons for complaints received for products manufactured at a Contract manufacturing organization (CMO) / LL (Loan Licensing) / TP (Third Party). Coordinate with manufacturing sites /designated QA person to initiate an investigation and complete within defined timelines with appropriate CAPA implementation.
  • Follow up for timely assessment and the preliminary response of critical complaints and assessment of FARs/RARs, preliminary complaint sample evaluation wherever applicable related to complaints.
  • Review of investigation reports received from site I&C team. Guidance for good report writing and root cause analysis, Assisting with clearance of complaint samples from imports team. 
  • Simplify and update SOPs – Market complaints, FAR handling, and Recalls as per the actual practices. Initiation of Change controls related to Job functions.

Desired Candidate Profile:

  • Functional knowledge of pharmaceutical manufacturing processes & Quality Management systems.
  • Functional knowledge of Quality Control & Microbiology laboratory. Investigation and Problem-solving skills.
  • Knowledge of manufacturing equipment, HVAC system, and water system.
  • Knowledge of manufacturing processes of various formulations/ IPQA. Knowledge of Quality control.
  • Ability to manage multicultural Product Complaint handling processes.
Educational Qualifications

M.Pharma

Experience:

12-15 Years

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