regulatory compliance specialist - India - beBeeChangeManagement

    beBeeChangeManagement
    beBeeChangeManagement India

    1 week ago

    Job title: Quality Change Control Specialist

    Description

    Job Overview

    We are seeking a skilled professional to manage change control activities in the pharmaceutical manufacturing sector. This role will partner closely with quality, manufacturing, validation, and engineering teams to ensure effective implementation of changes that adhere to global regulatory standards.

    Main Responsibilities

    • Analyze the impact of proposed changes on various aspects such as quality, manufacturing, validation, and regulation
    • Ensure compliance with cGMP requirements and FDA regulations including 21 CFR Parts 210 and 211
    • Maintain accurate documentation within electronic systems for easy reference during audits or inspections

    In addition to these core responsibilities:

    • This position requires strong documentation skills along with excellent coordination abilities

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Regulatory compliance specialist