Job Title:
Senior Quality Systems Professional
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Job Overview:
Our company seeks a seasoned Senior Quality Systems Professional to lead the development and implementation of quality systems, ensuring compliance with regulatory requirements.
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Key Responsibilities:
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* Develop and maintain site quality systems, procedures, and processes.
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* Provide quality direction at Change Control and Deviation Review Boards.
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* Ensure sustained compliance initiatives, including execution of gap assessments and management of Quality Risk Management (QRM) Processes.
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* Own and manage key quality systems, including Change Control, Deviation/CAPA processes, and Documentation Management.
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* Responsible for trending programs associated with Deviation/CAPA, Change Control, Complaints, Periodic Reviews, QRM, and providing key indicators as to program efficacy.
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* Challenge current procedures and practices, interpretation of trend data, and making necessary revisions to quality programs to afford optimization and further development of existing quality standards.
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Requirements:
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* University degree in an Engineering or Science related discipline.
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* Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
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* Experience working in aseptic operations, protein formulation, vial and syringe filling.