Quality Assurance Analyst - Mississauga, Canada - Novo Nordisk

Novo Nordisk

Verified Company

Mississauga, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

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 nonconformity 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 cGMP deficiencies, recommend and implement appropriate CAPA
Drive nonconformity 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 nonconformities 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 multitask under tight deadlines and work with mínimal 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 openoffice 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:
August 25, 202 3

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.