Specialist - Consulting

LTM; Canada; On-site; CAD 110,000 - 150,000; Full time

Benefits offered by this job

Comprehensive Medical Plan Covering 医療

Health Care Spending Account

Short Term and Long-Term Disability

Life Insurance

Annual vacation and other Paid Leaves

Maternity Leave Top Up Pay

Job summary

LTIMindtree Canada seeks a QA/QMS professional with strong knowledge of pharmaceutical QMS laboratory systems spanning the complete lifecycle. You will handle Veeva deviations and CAPA, raise ITCRs in ServiceNow with proper change descriptions, and perform root cause analyses and validation activities across laboratory systems.

The role requires experience with ValGenesis validation tools, extensive understanding of 21 CFR Part 11, GAMP 5 and other GxP standards, and crafting qualification

Qualifications

• 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.

Responsibilities

• 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.

Skills

QMS Laboratory Systems

Veeva Deviations

CAPA

ServiceNow ITCR

IT CAPA

ValGenesis

21 CFR Part 11

GAMP 5

GxP standards

Qualification Protocols

Patch Management

Postimplementation Review

Tools

Veeva

ServiceNow

ValGenesis

Job 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

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 [e-mail] so that arrangements can be made for the appropriate accommodations to be in place.