Quality Assurance Analyst (Two Positions Available)

PURPOSE

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 and Maintaining Establishment Licenses.

ESSENTIAL FUNCTIONS

• 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
• Systems Management (20% of time spent)
  • Manage training and use of OmniRIM system within the Canadian affiliate
  • User for Temperature Monitoring Device

PHYSICAL REQUIREMENTS

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.

QUALIFICATIONS

• Education and Certifications
  • Bachelor of Science Degree or equivalent experience
  • Post-Graduate RA/QC Certificate is considered an asset
• Work Experience
  • 3 to 5 years of experience in Quality Control, Quality Assurance and auditing.
  • Experience in Establishment License regulations and requirements

• Knowledge, Skills, and Abilities
  • Strong technical knowledge of pharmaceutical manufacturing, quality assurance, GMP, and Health Canada Guidelines
  • 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

APPLICATION DEADLINE: December 10th, 2024

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please email us at cami-hr@novonordisk.com

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.