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”):

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.

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.