IT Quality/Validation Specialist
This role at Roche focuses on end-to-end quality and validation tasks within the RDT Pharma R&D division. You will manage complex business problems, lead root cause analysis, and ensure compliance with software validation regulations. The position requires strong expertise in risk-based quality assurance, Agile methodologies, and experience with industry-standard tracking tools. You will act as a subject matter expert and mentor for team members in a cross-functional environment.
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Experience
7-14 years
Function
Quality Assurance
Work mode
Onsite, India
Company
Tier 2
What you will work on
This role at Roche focuses on end-to-end quality and validation tasks within the RDT Pharma R&D division. You will manage complex business problems, lead root cause analysis, and ensure compliance with software validation regulations. The position requires strong expertise in risk-based quality assurance, Agile methodologies, and experience with industry-standard tracking tools. You will act as a subject matter expert and mentor for team members in a cross-functional environment.
TAL's take
High-impact role at a major global healthtech company with clearly defined senior-level responsibilities.
The JD provides a very clear scope, defining responsibilities in validation, compliance, stakeholder management, and mentorship within a specific healthtech domain.
Must haves
- 7-14 years of relevant experience
- Experience managing end-to-end quality analysis tasks
- Deep understanding of computer system assurance/validation approaches
- Proficiency in Agile/SCRUM methodology
- Familiarity with 21 CFR Part 11 and Annex 11 regulations
Tools and skills
About the company
Global pharmaceutical and diagnostics company with substantial engineering and IT operations, categorized as tier 2 for non-tech-native sector.
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