Assistant Manager, Quality Assurance - Quality Managment System

8 - 15 years

30 - 35 Lacs

Posted:5 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

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:

  • Education:

    B.Pharm / M.Pharm
  • Experience:

    Minimum 8 15 years of experience in QA Documentation with Pharma Formulations
  • Strong understanding of cGMP, QMS, and regulatory requirements (WHO, EU, etc.)
  • Hands-on experience with QRA, Cleaning Validation, VMP, and other QMS elements.
  • Familiarity with document control software and electronic QMS tools is an advantage.

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Pelltech Healthcare logo
Pelltech Healthcare

Healthcare Technology

San Francisco

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