At a Glance
- Tasks: Manage Pharmaceutical QMS Laboratory systems and ensure compliance with regulations.
- Company: Join LTIMindtree, a leader in consulting and technology solutions.
- Benefits: Comprehensive medical plan, paid leaves, and performance bonuses.
- Other info: Diverse workplace committed to accessibility and equal opportunity.
- Why this job: Make a real impact in the pharmaceutical industry while growing your career.
- Qualifications: Experience with Veeva Deviations, CAPA, and laboratory system validation.
The predicted salary is between 62100 - 75900 $ per year.
Strong knowledge of Pharmaceutical QMS Laboratory systems covering the complete lifecycle.
Knowledge of handling Veeva Deviations and CAPA:
- Raising deviation processing investigation causal analysis implementation efficacy closure and other requirements per customers SOP.
- Raising an ITCR in ServiceNow with proper description, reason for change, implementation plan, impact assessment and other requirements per customers SOP.
- Raising an IT CAPA and processing root cause analysis.
- Monitoring deviations and CAPAs for extension amendment approval and closure.
Experience in validation of Laboratory Systems.
Hands-on experience with ValGenesis validation tool.
ITCR Monitoring through closure.
Good understanding of 21 CFR Part 11 and GAMP 5 and other GxP standards.
Drafting and execution of qualification protocols.
User access review.
Create and Review requirements specification for compliance with the applicable regulatory requirements.
Knowledge of Patch management.
Conduct post-implementation periodic review of systems.
Specialist – Consulting in Winnipeg employer: LTM
At LTIMindtree, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration. Located in Mississauga, Ontario, our team thrives in a high-performance environment where employees are encouraged to grow through continuous learning and exposure to cutting-edge technology in the financial sector. With comprehensive benefits, including a robust medical plan and generous paid leave, we ensure our employees feel valued and supported as they contribute to the evolution of electronic trading.
