LTIMindtree

Senior Specialist - Consulting

LTIMindtree • $80K — $110K *
Mississauga, ON L4T 0A1In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 5-7 years of experience in Pharmaceutical Quality Management Systems (QMS)
  • Proficient in Veeva for handling Deviations and CAPA
  • Experience with ServiceNow for IT Change Requests (ITCR)
  • Hands-on experience with ValGenesis validation tool
  • Strong understanding of regulatory standards such as 21 CFR Part 11 and GAMP 5
  • Skilled in drafting and executing qualification protocols
  • Knowledgeable in Patch management and conducting periodic system reviews.

Responsibilities

  • Manage the lifecycle of Pharmaceutical QMS Laboratory systems
  • Conduct causal analysis for investigation of deviations
  • Prepare and monitor ITCR submissions in ServiceNow
  • Process CAPAs and perform root cause analysis
  • Oversee the approval and closure of deviations and CAPAs
  • Draft and execute qualification protocols for laboratory systems
  • Perform user access reviews for compliance.

Benefits

  • Opportunity for hands-on experience with leading validation tools
  • Involvement in critical compliance processes for a reputable pharmaceutical organization
  • Exposure to a collaborative work environment focused on regulatory excellence
  • Potential for professional growth in pharmaceutical quality oversight
  • Engagement with cross-functional teams to enhance laboratory system effectiveness.
Full Job Description
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

About LTIMindtree

LTIMindtree is a global technology consulting and digital solutions company that enables enterprises across industries to reimagine business models, accelerate innovation, and maximize growth by harnessing digital technologies. As a digital transformation partner to more than 700+ clients, LTIMindtree brings extensive domain and technology expertise to help drive superior competitive differentiation, customer experiences, and business outcomes in a converging world. Powered by nearly 90,000 talented and entrepreneurial professionals across 30+ countries, LTIMindtree — a Larsen & Toubro Group company — combines the industry-acclaimed strengths of erstwhile Larsen and Toubro Infotech and Mindtree in solving the most complex business challenges and delivering transformation at scale.
Learn more about LTIMindtree
Industry
Information Technology
* Ladders Estimates

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