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Manager - Quality (QMS)

HINDCO Consulting Services

Thane | Navi Mumbai / Panvel | Mumbai

Not Disclosed

9 - 14 Years

Full Time - Permanent

Views:1024

Applicants:129

Posted on 17 Apr, 2025

In Office
Premium

Job Description | Responsibilities

  • Providing remote Quality Management System (QMS) support to global sites, focusing on the management of OOS investigations, laboratory incidents, deviations, and change controls.
  • Drafting and reviewing documentation, ensuring compliance with regulatory standards, and recommending continuous improvements.
  • Prepare and review OOS, OOT, and lab incident investigations, ensuring thorough analysis and initiation of change controls.
  • Review all planned and unplanned deviations for accuracy, completeness, and compliance with cGMP, data integrity, and written procedures.
  • Review of Protocol/Reports and APQR.
  • Collaborate with site teams to address identified gaps during QMS event review and drafting.
  • Engage with customers and site teams to ensure the timely closure of critical QMS events.
  • Coordinate with the site for review activities and planning to ensure smooth workflows.
  • Route documents through the Ensur application (or relevant platform) as needed across Piramal plants.
  • Participate in customer audits and regulatory inspections, providing support to site teams.
  • Lead and participate in additional tasks assigned by the Head of Department (HOD).

Overview

  • Industry - Pharmaceutical - Formulations
  • Functional Area - Quality - QC / QA / QMS / TQM / Lean / Six Sigma
  • Job Role - QMS Manager
  • Employment type - Full Time - Permanent
  • Work Mode - In Office

Qualifications

  • Any Graduate - Any Specialization
  • Any Post Graduate - Any Specialization
  • Any Doctorate - Any Specialization

Job Related Keywords

QMS Corporate Quality Assurance Pharma Formulations GLP QA USFDA Health Canada CGMP