09 Oct
|
Pharmatek Solutions
|
Bengaluru
09 Oct
Pharmatek Solutions
Bengaluru
Validation Lead – AI Product Quality & Compliance
• Location: Bangalore, India (full-time, on-site)
• Experience: 12-15 years
• Department: Quality / Product Validation
• Works with: Product, Development, QA, Regulatory/Compliance and SMEs
• Company: Klarixa Private Limited (a subsidiary of Pharma Tek Solutions, USA)
• Compensation: Competitive salary + meaningful equity from Day 0
• Location: BHIVE Workspace – HSR Campus, Hosapalaya, Bangalore (In-Office)
Company Website: http://www.klarixa.ai
Disclaimer: Please apply only if you meet the following experience & qulification criteria.
Required qualifications.
• Bachelor’s degree in engineering, Computer Science, IT, Pharmacy, Life Sciences or a related field.
• 12-15 years in CSV/CSA, software validation or QA in a regulated (pharma, biotech, medical device) setting.
• Working knowledge of GxP, GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+ and CSA.
• Hands-on authoring and review of validation plans, risk assessments, test cases, RTM and summary reports.
• SDLC and Agile/Scrum experience; strong technical writing; able to run validation independently.
Preferred experience
• Validating SaaS, web-based or multi-tenant pharma applications.
• E-records and signatures, audit trail, role-based access, workflow, document management or eQMS applications.
• AI/ML or LLM-enabled system validation, APIs and integrations.
• Test automation and tools such as Jira, Confluence or Azure DevOps.
Core competencies.
• Constructively challenges requirements and test coverage, clear written and verbal communication.
• Attention to detail, ownership and accountability.
• Comfortable in a quick-moving startup environment: hands-on and flexible on priorities.
Role summary
Klarixa is hiring a hands-on Senior Validation Engineer to own risk-based validation of its AI-enabled software product, from requirements through release and ongoing lifecycle. You will ensure the product is built, tested and released to GxP, data integrity and C
📌 Senior Validation Engineer (Bengaluru)
🏢 Pharmatek Solutions
📍 Bengaluru