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 postimplementation periodic review of systems
Vacancy Type: New Vacancy
Benefits/perks listed below may vary depending on the nature of your employment with LTIMindtree Canada ("LTIMC"):
Benefits and Perks:
- Comprehensive Medical Plan Covering Medical, Dental, Vision
- Health Care Spending Account
- Short Term and Long-Term Disability Coverage
- Life Insurance
- Annual vacation and other Paid Leaves
- Maternity Leave Top Up Pay
The range displayed on each job posting reflects the total compensation range for the position across all Canada locations. Within the range, individual pay is determined by work location and job level and additional factors including job-related skills, experience, and relevant education or training. Depending on the position offered, other forms of compensation may be provided as part of overall compensation like an annual performance-based bonus, sales incentive pay and other forms of bonus or variable compensation.
Role description
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 postimplementation periodic review of systems
Other details
Vacancy Type: New Vacancy
Benefits/perks listed below may vary depending on the nature of your employment with LTIMindtree Canada ("LTIMC"):
- Comprehensive Medical Plan Covering Medical, Dental, Vision
- Health Care Spending Account
- Short Term and Long-Term Disability Coverage
- Life Insurance
- Annual vacation and other Paid Leaves
- Maternity Leave Top Up Pay
The range displayed on each job posting reflects the total compensation range for the position across all Canada locations. Within the range, individual pay is determined by work location and job level and additional factors including job-related skills, experience, and relevant education or training. Depending on the position offered, other forms of compensation may be provided as part of overall compensation like an annual performance-based bonus, sales incentive pay and other forms of bonus or variable compensation.
Disclaimer: The compensation and benefits information provided herein is accurate as of the date of this posting.
LTIMindtree is an equal opportunity employer that is committed to diversity in the workplace. Our employment decisions are made without regard to race, color, creed, religion, sex (including pregnancy, childbirth or related medical conditions), gender identity or expression, national origin, ancestry, age, family-care status, veteran status, marital status, civil union status, domestic partnership status, military service, handicap or disability or history of handicap or disability, genetic information, atypical hereditary cellular or blood trait, union affiliation, affectional or sexual orientation or preference, or any other characteristic protected by applicable federal, state, or local law, except where such considerations are bona fide occupational qualifications permitted by law.
Accessibility and Reasonable Accommodation
LTIMindtree has an accommodation process in place and provides accommodations for applicants with disabilities. If you require a specific accommodation because of a disability or a medical need, please write to us at applicantaccommodation.canada@ltimindtree.com so that arrangements can be made for the appropriate accommodations to be in place.
Specialist - Consulting in Ottawa 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.
