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    • Assistant General Manager QA - Ahmedabad - Biotech Healthcare

    Biotech Healthcare
    Biotech Healthcare Ahmedabad

    1 month ago

    Default job background
    Upper Management / Consulting
    Description

    Role Overview

    A key objective of this position is to design, implement and enhance organizational work practices that align with quality management principles. The role will focus on establishing a culture of continuous improvement, compliance and operational excellence within the organization.

    Responsibilities

    • Quality Management System (QMS) Development:
      Design, implement, and maintain a robust QMS framework in line with regulatory requirements and industry standards.
    • Compliance & Documentation:
      Oversee the approval process for Site Master Files, Validation Master Plans, Quality Manuals, and stability summary reports.
    • Audit & Risk Management:
      Lead internal audits and self-inspections to assess compliance with quality standards and identify areas for improvement.
    • Project Leadership:
      Drive quality improvement projects and initiatives, collaborating with multidisciplinary teams to enhance operational efficiency and compliance.

    Requirements

    • Functional Skills:
      • Strong expertise in Quality Assurance, QMS implementation, and regulatory compliance.
      • Proficiency in managing quality projects, conducting internal audits, and performing gap analyses.
      • In-depth understanding of GMP, GDP, ISO 13485, and FDA regulations.
    • Behavioral Skills:
      • Leadership and Team Management: Ability to guide, motivate, and develop team members towards achieving organizational goals.
      • Attention to Detail: High level of precision in reviewing documents, managing audits, and ensuring compliance.
      • Problem-Solving & Analytical Thinking: Strong capability to identify issues, analyze root causes, and implement effective solutions.
      • Communication & Interpersonal Skills: Excellent communication skills, with the ability to interact effectively with stakeholders at various levels.
      • Adaptability & Change Management: Ability to adapt to changing business needs and lead initiatives for continuous improvement.

    About Us

    {company} is an Equal Opportunity Organisation promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etc.

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