Quality Assurance Coach

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 Document and QMS Specialist

 

Job Summary

The IT QMS and Training Specialist is responsible for supporting and maintaining the IT Quality Management System (QMS) and associated training programs to ensure compliance with applicable regulations, standards, and internal procedures. This role partners closely with IT, Quality, and business stakeholders to ensure IT processes, systems, and personnel meet regulatory and organizational requirements.

 

Key Responsibilities

IT Quality Management System (QMS)

• Support the development, implementation, and maintenance of IT QMS processes, procedures, and documentation.
• Ensure IT policies, SOPs, templates, and work instructions align with regulatory requirements (e.g., FDA, ISO 13485, ISO 27001, GxP, as applicable).
• Manage controlled documents within the electronic QMS (eQMS), including document lifecycle activities (authoring, review, approval, revision, and retirement).
• Support IT audits, inspections, and assessments by preparing documentation, responding to auditor questions, and tracking corrective actions.
• Collaborate with IT and Quality teams to ensure validation and qualification deliverables align with QMS requirements.
• Track and support CAPAs, deviations, and change management activities related to IT systems and processes.

 

Training Management

• Create and administer the Training Matrix, IT training program and Learning Management System (LMS), ensuring accuracy and compliance.
• Coordinate onboarding and role‑based training for IT personnel and system users.
• Assign, monitor, and report on required and recurring training.
• Ensure training content is current, effective, and aligned with QMS documents and system use.
• Support training effectiveness assessments and audit readiness.

 

Cross‑Functional Collaboration

• Act as a liaison between IT, Quality, and business stakeholders.
• Provide guidance to IT teams on QMS and training requirements.
• Support SaaS/vendor oversight activities as they relate to IT quality and training expectations.

 

Continuous Improvement

• Identify opportunities to improve IT QMS efficiency, documentation clarity, and training effectiveness.
• Support QMS metrics, reporting, and trending activities.
• Assist with process harmonization and standardization initiatives.

 

Required Qualifications

• Bachelor’s degree in Information Technology, Computer Science, Quality, Life Sciences, or a related field (or equivalent experience).
• 3+ years of experience in IT Quality, QMS, Compliance, and/or Training in a regulated environment.
• Hands‑on experience with eQMS and LMS platforms.
• Strong understanding of IT controls, system documentation, and regulated and non-regulated environments.
• Experience supporting audits and inspections.
• Excellent written and verbal communication skills.

 

Preferred Qualifications

• Experience in medical device, pharmaceutical or biotech.
• Knowledge of FDA QSR, ISO 13485, GxP, ISO 27001 and GxP.
• Experience with system validation/qualification (IQ/OQ/PQ).
• Risk‑based thinking
• Continuous improvement mindset

 

 

 

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

Experience Level

Mid Level