Senior Quality Assurance Specialist
York, England, United Kingdom
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/personnel for the business, emphasizing compliance in areas such as Quality Issues, Change Controls, and CAPAs. Lead the development and execution of Quality Improvement projects. Develop, implement, and maintain auditing strategies to ensure ongoing compliance with current regulations and guidelines. Independently monitor all study types conducted within BioA … as required by regulations and SOP. Conduct various types of Quality Assurance audits, including process, facility, SOP, CSV, and study audits. Review and maintain the BioA Central Events log, ensuring timely completion of proposed corrective and preventative actions (CAPA) by management. Act as Deputy Archivist, responsible for maintaining the … regulatory facility inspections. Participate in the review of root cause analysis, corrective action, and preventive action plans for internal, 3rd party, and vendor audits. Process Improvement Responsibilities: Lead the development, improvement, implementation, and maintenance of new/modified quality systems to ensure GLP and GCP compliance. Recommend more »
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