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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