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Job DescriptionQuality Systems Representative
o Member of the QO team in ensuring quality oversight at the manufacturing suite
o Partner the manufacturing team in the implementation and adherence to the various quality systems and GMP requirements at the manufacturing suite
o Participate in meeting with the manufacturing for information learning/sharing and alignment of best practices
o Support the compliance, regulatory, inspections and training activities as required and any other responsibilities as assigned by supervisor.
• QO Operations
o Support the manufacturing team with development and writing of process standard operating procedures, master batch records and Forms, ensuring compliance with current good documentation practices and the applicable global procedures and regulatory requirements.