GMP Compliance Expert

4 days ago


Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full time

Key Responsibilities

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The Manufacturing Readiness Coordinator II is responsible for coordinating and delivering readiness milestones to ensure right-first-time execution on the GMP manufacturing floor and timely starts. This role requires excellent coordination, organizational, and communication skills, as well as a strong understanding of bioprocessing equipment and processes.

Main Tasks

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  1. ">
  2. Process Preparation">
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    2. Draft and finalize process consumables lists for new client programs, working closely with cross-functional teams.">
    3. Prepare material specifications to enable purchasing and release of materials/consumables for GMP manufacture, collaborating with Supply Chain and Purchasing teams.">
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  3. Equipment Management">
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    2. Coordinate room/equipment changeovers, ensuring all equipment is properly cleaned and released prior to use.">
    3. Schedule Preventive Maintenance/Corrective Maintenance tasks as needed, working collaboratively with Facilities.">
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  4. Documentation and Compliance">
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    2. Author batch records, generate SOPs and applicable forms for new equipment, and route them through the document control system, ensuring compliance with regulatory requirements.">
    3. Support Failure Modes and Effects Analysis (FMEA) risk assessments and Potential Problem Analysis (PPA) events.">
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  5. Continuous Improvement">
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    2. Contribute to a proactive approach to identifying and mitigating potential issues through collaborative efforts with the Quality Assurance team.">
    3. Promote a culture of continuous improvement within the manufacturing organization.">
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Requirements

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To excel in this role, you must have a strong background in bioprocessing operations, excellent communication and interpersonal skills, and proficiency in Microsoft Office applications. Experience working in cleanroom environments and familiarity with material control and testing requirements are highly desirable.



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