Functional QA Pharma, Cell & Gene Therapy
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Job Location:
Monthly Salary:
Experience Required:
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
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.
Company Industry
IT Services and IT Consulting
Key Skills
- Change Management
- Corporate Communications
- Apache Commons
- Compensation
- Civil Quality Control
