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Quality Assurance Analyst
Location:
Mississauga
Description:
Quality Assurance Analyst (12 Months Contract) Purpose of the Job The Quality Assurance Analyst is responsible for: Performing Quality audits and activities Ensuring products are released to Market Authorization Managing non-conformity and change control process Key Areas of Responsibilities Product Release: (50% of time spent) Ensure all appropriate importation checks are completed prior to product (Marketed and Clinical Trials) release Ensure all products received meet Market Approval and comply with GMPs Investigate discrepancies in all production documents provided by Manufacturing Facilities, 3rd Party Packagers and 3PL. Ensure compliance to Market Authorization, Novo Nordisk Quality Management System and GMPs Liaise with Health Canada and 3PL to release product GMP Compliance Monitoring: (30% of time spent) Identify GMP or c GMP deficiencies, recommend and implement appropriate CAPA Drive non-conformity and change control process Author, manage and implement SOPs Engage in complaint handling/investigations into product failures for drugs and medical devices Engage in product recalls or voluntary market withdrawals, as needed Support preparation of Annual Product Reviews and Yearly Biologic reports to Health Canada Support Establishment Licenses (Drugs and Devices) renewals/amendments Other activities include training, investigations, trend analysis System Management: (20% of time spent) Manage Quality systems for deviations, change management, Procedures, Audits, and training within the Canadian affiliate Key Compliance Accountabilities Release of product to current Health Canada Authorization (Clinical and Marketed) Prepare yearly biologics reports for Health Canada Document and investigate non-conformities and deviations Plan and conduct internal and external audits Comply with Novo Nordisk Quality Business Processes and Policies as outlined in the Quality Management System Goals Responsible for the daily operation of Quality Assurance Department, assuring. Visit ListedBuy for more information.
Company:
Novo Nordisk
Posted:
December 16 2023 on ListedBuy
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Quality Assurance Analyst is a Other Art & Media Jobs QA Analyst Job at Novo Nordisk located in United States. Find other listings like Quality Assurance Analyst by searching Oodle for Other Art & Media Jobs QA Analyst Jobs.
Quality Assurance Analyst is a Other Art & Media Jobs QA Analyst Job at Novo Nordisk located in United States. Find other listings like Quality Assurance Analyst by searching Oodle for Other Art & Media Jobs QA Analyst Jobs.