04 Sep
|
Yash Technologies
|
Bengaluru
04 Sep
Yash Technologies
Bengaluru
Job Description
Summary
Ownership of Validation Artifacts
- Leads the help for creation, review, and approval of validation documents such as:
- Validation Plans
- Test Plans
- Security Plans
- Validation Summary Reports
- Requirements Traceability Matrices etc.
- Review CR
Creation/Performance of CAPA
Cross-Functional Collaboration
- Works closely with system owners, business SMEs, test leads, and quality assurance teams to ensure validation deliverables meet compliance and operational standards.
Regulatory Compliance
- Ensures validation activities align with regulatory expectations (e.g., GCP, FDA, CSA), and supports audit readiness.
Project Leadership
- Coordinates validation timelines, manages document routing and approvals, and ensures testing cannot proceed without validated documentation.
Tool & System Familiarity
- Uses platforms like Jira, ALM, and internal document management systems (e.g., Qdocs) for validation tracking and documentation.
Review & Routing.
- Often the final reviewer in validation workflows, ensuring completeness and compliance before sign-off.
External :
- Strategic Leadership: Define and implement validation strategy for a current manufacturing site.
- Technical Documentation: Author and approve validation master plans, protocols, SOPs, and summary reports.
- Cross-Functional Integration:
Collaborate with Quality Control, Engineering, Operations, and QA.
- Problem Solving: Anticipate and resolve complex validation issues with site-wide impact.
- Regulatory Support: Assist in regulatory filings and ensure audit readiness.
Summary of Core Competencies
- Domain Expertise - GxP/GMP compliance, Computer Software Assurance (CSA), validation lifecycle
- Tools - Jira, ALM, Qdocs, Document Management Systems
- Soft Skills - Leadership, collaboration, attention to detail, regulatory awareness
- Deliverables - Validation plans, test scripts, traceability matrices, summary reports
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
📌 Test Lead - Validation Testing Job (Bengaluru)
🏢 Yash Technologies
📍 Bengaluru