HireDiversity

Toronto, ON, CA

Quality Compliance Specialist (Contract) - Janssen Inc., - Toronto, ON-0484130130

Description

As a member of the Janssen Pharmaceutical Companies of Johnson & Johnson, Janssen Inc. is dedicated to addressing and solving the most important unmet medical needs in pain management, psychiatry, oncology, psoriasis, virology, anemia, attention deficit hyperactivity disorder, dementia, gastroenterology and women's health. Driven by our commitment to the passionate pursuit of science for the benefit of patients, we work together to bring innovative ideas, products and services to patients around the world.

Position Overview

Janssen Inc. is looking to fill a Quality Compliance Specialist - 9 month contract role in our Quality Management department. The position will be based in Toronto, Ontario

Key responsibilities:

Update of product specifications/standards to ensure compliance with Marketing Authorization.

Update Certified Product Information Documents (CPIDs) and prepare Level III and IV internal submissions.

Work in close partnership with Global RA, Supply Management and external supply sites ensuring effective change assessment and implementation.

Support other Quality Systems or functions as required (e.g. Complaints, Non-conformances, CAPAs, Records Management).

Evaluate and report the process metrics.

Provide support to Annual Product Quality Review assessment, Annual Stability Report review, executed batch record review and master record GMP checks.

Provide support for review of Manufacturing and Packaging Validation protocols and reports.

Initiate CAPAs and non-conformance reports as required

J2W:LI

Qualifications


BSc in Pharmacy, Chemistry, Microbiology, Biotechnology or Biochemistry is required.

Strong analytical thinking.

Superior attention to accuracy and details.

Strong communication (verbal, written) and project management skills.

Ability to work independently and in cross-functional team settings.

Strong knowledge of cGMPs.

Proficient with Microsoft Office applications.

3 to 5 years of quality systems pharmaceutical experience.

Experience in a pharmaceutical manufacturing environment is preferred.

Regulatory Affairs experience an asset.

BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.

Primary Location:North America-Canada-Ontario-Toronto
Organization: Janssen Inc. (7710)
Job Function: Quality (Generalist)