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Fort Lauderdale

    Quality Control Validation Specialist - Fort Lauderdale, United States - Katalyst HealthCares & Life Sciences

    Katalyst HealthCares & Life Sciences
    Katalyst HealthCares & Life Sciences Fort Lauderdale, United States

    3 weeks ago

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    Description
    Responsibilities:
    • Method Development and Qualification/Validation: Lead the design, development, and qualification/validation of analytical methods aimed at assessing critical quality attributes of raw materials, drug substances, intermediates, and products.
    • Data Processing: Skillfully process data generated from Qualification and Validation, ensuring accurate and comprehensive report generation.
    • Regulatory Compliance: Ensure that the evaluation and testing of GBI products align with regulatory standards, scientific best practices, and are completed within established schedules.
    • Documentation Oversight: Review, write, and supervise the execution of input and output reports and Standard Operating Procedures (SOPs).
    • Timely Data Finalization: Ensure that all analytical raw data is reviewed and finalized within the stipulated timeframes.

    Requirements :

    • Minimum of five years of direct work experience in an FDA-regulated environment.
    • Problem-Solving: The candidate should be a proficient problem-solver, demonstrating the ability to exercise sound judgment under challenging circumstances.
    • Communication: Excellent written and verbal communication skills with the ability to effectively promote cooperation within and between departments.
    • Regulatory Knowledge: In-depth knowledge of GMP, ICH, and compendial requirements and their application for the Qualification and Validation of Analytical methods for Large Molecules.
    • Attention to Detail: Strong attention to detail, observation, organizational, and leadership skills.
    • Personal Integrity: Possess strong character with self-confidence and integrity.
    • Time Management: Demonstrated time management skills to ensure efficiency in project execution.
    • Critical Thinking: The ability to think critically and make informed decisions based on analytical assessments
    • Bachelor's degree in biological or biochemical sciences or a related field.
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