Specialist - Consulting

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, GAMP 5 and other GxP standards
• Drafting and execution of qualification protocols
• User access review
• Create and review requirements specification for compliance with applicable regulatory requirements
• Knowledge of Patch management
• Conduct postimplementation periodic review of systems

Skills

Mandatory Skills: Regulatory & Compliance - Computer system validation

Other details

Vacancy Type: New Vacancy

Benefits and Compensation

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

Compensation range: $100,000.00 to $105,000.00 per year

The compensation and benefits information provided herein is accurate as of the date of this posting.

Equal Opportunity

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 View email address on ca.talent.com so that arrangements can be made for the appropriate accommodations to be in place.