* This is not a typical QA role. There is no QMS for you to maintain. You will build one. * Most QA roles ask you to follow, update and audit a quality system someone else designed. This one asks you to design, write, launch and own the Quality Management System of a regulated software business, from the ground up. And the QMS you build will run on a product we’re building ourselves. If you’ve ever looked at a QMS and thought “I would have built this differently”, this is your chance to do it.

About us
Technopath Consulting is a niche UK consultancy specialising in process automation and AI. We help organisations rethink how work gets done, so that it’s automated where it should be, intelligent where it helps and controlled where it matters. We’re now building that expertise into our own products for regulated industries:
• Route9: an application for computerised system validation and for document management, including review and approval.
• RoshamAI: our AI platform. Our offshore development centre, Rete BPO Services Pvt. Ltd. (RBS) in India, is home to our development and test team. This role is employed by RBS and works directly with Technopath’s Director. What you’ll build
• The QMS architecture: quality manual, quality policy and the full SOP set, covering document control, training, quality risk management, SDLC and CSV, change control, supplier management, deviations and CAPA, access and security, backup and recovery, data protection, release management, periodic review, internal audit, complaints and management review. Plus the forms, templates, registers and training matrix that make the SOPs work in practice.
• A QMS that runs on Route9: our own document review, approval and training workflows will run in Route9.



You’ll define how controlled documents, e-signatures, training and quality records must behave, and you’ll see those requirements become the product.
• Quality inside an agile, cloud-native SDLC: risk-based CSV aligned with GAMP 5 (2nd edition) for SaaS products on Google Cloud with CI/CD pipelines. You’ll define what a validated release looks like: validation plan, URS, specifications, risk assessments, traceability, IQ/OQ/PQ and release records.
• AI governance: how AI is assessed, evaluated, controlled and monitored when it’s used in GxP work, both in our products and in our own processes, taking into account emerging expectations such as EU GMP Annex 22 and the EU AI Act.
• Supplier and partner assurance: qualifying our cloud providers and other critical suppliers.
• Audit readiness: an internal audit programme, management review and quality KPIs. You’ll be our quality voice when customers audit us.
• Shaping Route9 from the inside: as our in-house quality and validation expert, you’ll help make sure Route9 does what validation and quality teams really need. You won’t be starting alone. We use AI heavily, including for first drafts. What we need from you is the judgement and experience to turn drafts into a working system that people actually follow and that passes audit. What you bring




• You have built a QMS from scratch at least once: at a start-up, a new site, a spin-off or a software vendor. This is essential; please tell us about it in your application.
• 6+ years in pharma, biotech, medical devices or GxP software quality.
• Strong working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, ICH Q9 and data integrity (ALCOA+).
• Experience with computerised system validation, ideally of SaaS or cloud systems.
• You write clear, practical SOPs that people can follow, not documents that only auditors read.
• You’ve hosted or led audits (customer, supplier or regulatory).
• You’re comfortable with AI tools and curious about how AI should be governed in regulated work.
• Excellent written and spoken English. Nice to have
• Experience in a software vendor or SaaS quality role
• Hands-on use of an eQMS or electronic document management system
• ISO 9001, ISO 13485, ISO/IEC 27001 or ISO/IEC 42001 exposure
• Lead auditor certification This role is probably not for you if… most of your experience is executing test scripts or maintaining a QMS someone else designed. We value that experience, but this role is about building.

What we offer
• Real ownership: your name on the Quality Manual
• Influence on a product built for quality and validation professionals
• Direct work with the Director, with no layers of management
• Fully remote, anywhere in India
• Full-time employment with RBS, or a long-term full time freelance contract To apply, send your CV with a short note (no more than one page) about a QMS you built from scratch: its scope, how many SOPs, how long it took to go live, and how its first audit went.

📌 Quality Consultant – Build a GxP QMS from Scratch (India)
🏢 Technopath Consulting
📍 India