US-CA, Sr Quality Analyst QA Operations SR0042007-MZ
Successfully perform all primary activities which include providing daily quality assurance to operations, review of electronic batch records and associated documents within the manufacturing facility, provide support on change control processes, and participate and support internal and external audits.
Assure compliance with GMP, GDP, GLP, and company procedures. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines, and Takeda Quality practices.
Review electronic batch records and associated documents against procedures for accuracy and assure compliance to procedures based on regulatory requirements and internal guidelines, etc.
Provide assessments to support day to day change control processes (insignificant changes and return to operations) in accordance with internal procedures and ensure compliance with the FDA and ISO requirements.
Good understanding and knowledge of current regulatory requirements i.e., EBM, Delta V, JD Edwards, LIMS, FDA, ISO, and Takeda Quality Systems, and serve as a plant resource for compliance to these requirements.
Essential Duties and Responsibilities
Education and/or Experience
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