Need qualification of IQ/OQ/PQ and Viva QualityDocs or QMS experience desirable

Key Responsibilities

- Solid Analytical skills with demonstrated ability to troubleshoot complex process/system issues. Understanding of applicable international and national laws, regulations and standards: FDA (CSV & CSA), ISO and EU regulations for medical devices and healthcare; especially FDA 21CFR Part 820/Part 11, ISO 13485/EU MDR and EU Annex 11.
- Understanding of current inspectional practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessments or inspections.
- Knowledge and experience in key QMS disciplines (e.g. production and process quality control, design quality control, product risk management,



post market surveillance quality control as well as general QMS management) is preferred.
- High attention to detail.
- Solid organizational, writing/technical writing, (including clear logic and quality & regulatory compliance documentation approaches, good documentation practices), verbal, and interpersonal skills. Actively share knowledge and help solve problems with systemic issues driving positive, compliant impact, coaching/mentoring teams as well as assisting in problem-solving for systemic issues.

Pay: ₹450,000.00 - ₹1,000,000.00 per year

Benefits:

- Flexible schedule
- Internet reimbursement
- Work from home

Work Location: Remote

📌 Validation Engineer (India)
🏢 Velocity-RCS
📍 India