Assistant Manager, Quality Assurance - Quality Managment System

Job Summary

We are looking for a dedicated and detail-oriented Assistant Manager – Documentation with strong exposure to various Quality Management System (QMS) elements. The ideal candidate should have hands-on experience in managing QMS documentation including Quality Risk Assessment (QRA), Cleaning Validation, Market Complaints, Self-Inspection, Quarterly Review Reports, Site Master File (SMF), Quality Manual, and Validation Master Plan (VMP).

Key Responsibilities

• Manage and control QMS documentation in compliance with regulatory and company standards.
• Prepare, review, and update documents including :
• Quality Risk Assessments (QRA)
• Cleaning Validation protocols and reports
• Market Complaint investigation reports
• Self-Inspection reports
• Quarterly Product Quality Review (PQR) reports
• Site Master File (SMF)
• Quality Manual
• Coordinate with cross-functional teams (Production, QC, Engineering, Regulatory, etc.) to ensure alignment on documentation requirements.
• Assist in regulatory audits and inspections by maintaining ready and accurate documentation.
• Develop and implement documentation SOPs in accordance with cGMP and regulatory guidelines (WHO-GMP, EU GMP).
• Participate in training and qualification of staff on QMS documentation practices.
• Monitor document life cycle and ensure periodic review as per QMS requirements.
• Support continuous improvement initiatives and documentation harmonization efforts.

Qualifications & Experience

Skills Required

Cleaning Validation, Cgmp