Associate Lead Consultant - Validation Testing Job

YASH Technologies is a leading technology integrator specializing in helping clients reimagine operating models, enhance competitiveness, optimize costs, foster exceptional stakeholder experiences, and drive business transformation.

At YASH, we’re a cluster of the brightest stars working with cutting-edge technologies. Our purpose is anchored in a single truth – bringing real positive changes in an increasingly virtual world and it drives us beyond generational gaps and disruptions of the future.

We are looking forward to hire Validation Testing Professionals in the following areas :

Job description:

IT Quality & Compliance Specialist

Job Summary

The IT Quality & Compliance Specialist is responsible for ensuring that computerized systems supporting regulated business processes comply with applicable regulatory requirements and industry standards. This role partners closely with IT, Quality, and business stakeholders to implement and maintain compliant, risk‑based processes for system validation, change control, data integrity, and ongoing compliance, with an emphasis on Computer System Validation/Computer Software Assurance (CSA) principles.

Key Responsibilities

IT Quality & Compliance

• Ensure computerized systems comply with applicable regulations and standards, including 21 CFR Part 11, 21 CFR Part 820, EU GMP Annex 11, ISO 9001,ISO 13485 and other applicable global regulations
• Support internal and external audits and inspections related to IT systems and validation
• Identify, assess, and mitigate compliance and data integrity risks associated with computerized systems
• Contribute to the development, review, and maintenance of IT Quality and CSV/CSA policies, procedures and guidance

Computerized Systems Validation / Assurance

• Lead or support risk‑based validation and assurance activities using CSA and/or traditional CSV approaches
• Develop and review validation deliverables such as:
  • Validation Plans
  • Risk assessments (system or functional)
  • Test strategies and summaries
• Ensure validation activities are fit‑for‑purpose, focused on critical functions, and appropriately documented

Change and Lifecycle Management

• Review and approve IT system changes, upgrades, and configurations for compliance impact
• Assess vendor releases and changes for risk to intended use, validation state, and regulatory compliance
• Support ongoing system lifecycle activities, including periodic reviews and decommissioning activities

Vendor and Supplier Oversight

• Support vendor qualification and due diligence activities, including:
• Review of SOC reports and vendor documentation as app
• Assessment of vendor change and release management practices
• Partner with Procurement, IT, and Quality to ensure vendor controls are understood and leveraged appropriately

Stakeholder Collaboration

• Act as a trusted Quality and compliance advisor to IT and business teams
• Provide guidance and training on CSA/CSV expectations and best practices
• Promote a risk‑based, pragmatic, and value‑focused quality culture, minimizing over‑documentation while maintaining compliance

Qualifications

Education and Experience

• Bachelor’s degree in Information Technology, Computer Science, Engineering, Life Sciences, or a related field
• Typically 5+ years of experience in IT Quality, CSV/CSA, or regulated IT environments

Required Knowledge and Skills

• Strong understanding of:

• • GxP and regulated environments
  • FDA and EU regulatory expectations for computerized systems
  • Data integrity principles

• Experience with:

• • CSA and/or traditional CSV methodologies
  • Validation of SaaS, COTS, customized and configured systems
  • Risk‑based approaches to testing and assurance
• Familiarity with SDLC methodologies (Agile, Waterfall, Hybrid) and tools such as Jira, Confluence, and test management systems
• Excellent written and verbal communication skills
• Ability to balance compliance requirements with business efficiency

Preferred Qualifications

• Experience supporting FDA inspections or ISO audits
• Experience in medical device, pharmaceutical, or life sciences industries
• Familiarity with cloud‑hosted and SaaS platforms

At YASH, you are empowered to create a career that will take you to where you want to go while working in an inclusive team environment. We leverage career-oriented skilling models and optimize our collective intelligence aided with technology for continuous learning, unlearning, and relearning at a rapid pace and scale.

Our Hyperlearning workplace is grounded upon four principles

• Flexible work arrangements, Free spirit, and emotional positivity
• Agile self-determination, trust, transparency, and open collaboration
• All Support needed for the realization of business goals,
• Stable employment with a great atmosphere and ethical corporate culture