Pharma QMS Consultant: Deviations, CAPA & Validation

LTM; Canada; In loco; CAD 110.000 - 150.000; Tempo pieno

Vantaggi offerti da questo lavoro

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

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

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

Strumenti

Veeva

ServiceNow

ValGenesis

Descrizione del lavoro

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