Job Description

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Quality Assurance Analyst

Category: Quality

Location:

Mississauga, Ontario, CA

Quality Assurance Analyst

PURPOSE OF THE JOB

• The Quality Assurance Associate is responsible for:
• Performing Quality audits and activities
• Ensuring products are released to Market Authorization
• Managing non-conformity and change control process
• Maintaining Establishment Licenses

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 cGMP 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
• Perform Self-Inspections/External Audits and manage CAPAs to resolve observation/deficiencies
• Monitor Stability Programs
• Manage Annual Product Reviews and prepare Yearly Biologic reports to Health Canada
• Manage/Renew Establishment Licenses (Drugs and Devices)
• Other activities include training, investigations, trend analysis

System Management: (20% of time spent)

• Manage training and use of Archiving system within the Canadian affiliate
• User for Temperature Monitoring Device

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 compliance with GMPs, Regulations Novo Nordisk Quality Management System, and managing the daily department functions and quality responsibilities.

Education (Minimum Requirements):

• Bachelor of Science Degree or equivalent experience
• Post-Graduate RA/QC Certificate is considered an asset

Experience & Skills (Minimum Requirements):

Experience:

• 3 to 5 years of experience in Quality Control, Quality Assurance, and auditing.
• Experience in Establishment License regulations and requirements

Knowledge:

• Strong technical knowledge of pharmaceutical manufacturing, quality assurance, GMP, and Health Canada Guidelines.

Skills:

• Excellent organization, time management, and written/verbal communications skills
• Strong communication report writing, organization and project management skills
• Team player, able to multi-task under tight deadlines and work with minimal supervision
• Strong commitment to accuracy and details
• Exceptional interpersonal skills, ability to interact with staff, clients, and key stakeholders
• Proficiency in Microsoft Word and Excel

Working Conditions:

• Works in an open-office environment with exposure to multiple demands, deadlines, and constant interruptions
• Little exposure to hazards while performing the duties of the job
• Occasional exposure to warehouses during planned audits of vendors
• Travel to vendors throughout Canada and travel to Europe for global meetings.

Internal Application Deadline: November 12, 2022

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.