Assistant General Manager QA - india - Biotech Healthcare

    Biotech Healthcare
    Biotech Healthcare india

    1 hour ago

    Default job background
    Description

    Job Description:

    The successful candidate will design, implement, and enhance organizational work practices aligned with quality management principles. They will focus on establishing a culture of continuous improvement, compliance, and operational excellence within the organization.

    Key Responsibilities:

    • Develop and maintain a Quality Management System (QMS), ensuring comprehensive compliance across all operational processes.
    • Oversee approval processes for regulatory documents, ensure procedural compliance in handling deviations and market complaints, and conduct document reviews for new product launches.
    • Lead internal audits and self-inspections to assess compliance with quality standards, investigate quality-related issues, and implement corrective actions.
    • Drive quality improvement projects, collaborate with multidisciplinary teams to enhance operational efficiency and compliance, and support business continuity management plans.
    • Identify training needs, design comprehensive training programs on GMP, QMS, and regulatory compliance, and implement online training systems.

    Requirements:

    • Detailed understanding of regulatory requirements, including FDA, ISO 13485, GMP, and GDP.
    • Proven expertise in developing and implementing QMS processes, conducting internal audits, and performing gap analyses.
    • Strong leadership and team management skills, ability to guide, motivate, and develop team members towards achieving organizational goals.
    • Excellent communication and interpersonal skills, with the ability to interact effectively with stakeholders at various levels.

    Team Management:

    The ideal candidate will manage a team size of over 12 to 15 QA professionals, reporting directly to the Vice President of Corporate Quality.

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