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 Service Now 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 Val Genesis 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
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.
Roledescription
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 Service Now 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 Val Genesis 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
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…
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).