Senior Validation Consultant

2 weeks ago


Chandigarh, Chandigarh, India KVALITO Consulting Group Full time

About the Role

KVALITO Consulting Group is a strategic partner and global Life Science network for regulated industries with a focus on quality.

We are seeking a Validation Consultant to aid with the validation process.

The consultant will be responsible for ensuring standards and contributing to the development of an ISO certification framework.

Key Responsibilities

  1. Initiate and manage the validation process for client applications, ensuring compliance with CSV standards.
  2. Collaborate with development and design teams to gather and document user requirements, product specifications, and detailed design.
  3. Oversee the execution of the validation process, including development, testing, and backlog management.
  4. Conduct a gap analysis to identify areas of improvement for CSV, IT Security, and ISO certification frameworks.
  5. Develop a roadmap for implementing an ISO 27000 or ISO 27001 framework to ensure data security and compliance.
  6. Collaborate with stakeholders to define validation requirements, timelines, and deliverables for each client application.
  7. Ensure accurate documentation storage in JIRA and approvals through DocuSign.
  8. Provide regular updates to clients, project teams, and management regarding validation process progress.
  9. Collaborate with internal teams and external consultants to address technical challenges and ensure successful project completion.

Requirements

  • Bachelor's degree in computer science, engineering, or a related field.
  • Fluent in English, both written and spoken.
  • Minimum 5 years' experience in Agile CSV and IT Security, preferably in the pharmaceutical industry.

We Offer

  • Flat hierarchies and responsibility from the beginning.
  • People-oriented culture.
  • Diversity and inclusion-focused environment.
  • Global client projects in a multinational environment.
  • Flexible working hours and home office.
  • Involvement in global conferences.
  • Individual professional development, training, and coaching.
  • Unlimited full employment contract.
  • Excellent remuneration package consisting of a competitive salary plus a substantial bonus.


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