Functional QA - Pharma, Cell & Gene Therapy

Job Title:

Tester and Business Analyst QMS - Spark Integration

Location:

MISSISSAUGA, ONTARIO

Required Skill:
Business Analysis

Years of

Experience:

8-10 yrs

Top 3

Required Skills:

1. Knowledge of pharma and/or cell & gene therapy processes is a plus.

2.

Experience with business/end-user application – prior experience with patient access

3.

Experience with implementing Technical Operations System and Equipment

Top 3 Preferred

Skills:

1. Ability to write validation docs

2. knowledge of current GxP requirements

3. Familiar with Manufacturing, Quality, intercompany order processing, and outbound logistics processes.

About the role:

You will be assigned to a program called CGT that stands for Cell & Gene Therapy for support of Spark Integration. Required to be working closely with the global CGT Operations, partner management and Affiliate teams. Collaborates with IT Business Partners and/or Product Managers in business development

Responsibilities:

● Acts as an interface between business and IT functions in the area of Spark Integration including QMS replacement

● Acts as an Tester in the area of Spark Integration including QMS replacement

● Collaborate with IT Business Partners, Stakeholders, Product Owner and Development Team - Tester, Developer, IT Architects, Adoption Services, external Vendors.

● Strives for harmonisation of business processes across sites and departments by propagating common standardised data models, applications and technologies that are in line with the cross-functional or Informatics strategies and architectures.

● Explore opportunities and initiatives to grow professionally, in a self-assignment way and take additional roles as squad leads as appropriate.

● Displays skills and capabilities in the area of business partnering and/or product management.

● Demonstrate ability to perform detail-oriented work with a high degree of accuracy and able to explain complex concepts with clarity and simplicity.

● Demonstrate knowledge of current GxP requirements and documentation standards, with the ability to write validation docs

● Managing communications with multiple business units as well as internal IT cross-functional teams.

● Ensures delivery in line with Spark Integration Project

Candidate requirements:

● Knowledge of pharma and/or cell & gene therapy processes is a plus.

● Experience with business/end-user application – prior experience with patient access or physician portals a plus.

● Project-based work experience in the pharmaceutical industry

● Experience with implementing Technical Operations System and Equipment

● Familiar with Manufacturing, Quality, intercompany order processing, and outbound logistics processes.

● Constantly looking for improvements in ways of working (Process/tools/organisation) and works independently.

● Ability to understand technical processes, with strong communication skills and the ability to train/coach others

● Good communication skills - fluent in written and spoken english.