Job Title: Sr Manager / Lead – CSV QA (IT QMS | ISO Audits | Compliance)
Location: Noida (Work from Office – 5 Days)
Experience: 10–15 Years
Salary: ₹25,00,000 – ₹30,00,000 per year
Company: RxLogix Corporation India Pvt Ltd
Job Overview
We are looking for a seasoned IT Quality Assurance professional with strong expertise in Computer System Validation (CSV), Quality Management Systems (QMS), and ISO audits.
Note: This role is NOT suitable for software testing (manual/automation) professionals.
Key Responsibilities
- Drive and maintain IT Quality Management System (QMS)
- Lead internal and external ISO audits (ISO 9001 & ISO 27001)
- Review and manage CSV deliverables (URS, Validation Plan, Traceability Matrix, Test Summary Reports)
- Review IQ/OQ/PQ qualification scripts and reports
- Implement SOPs, process improvements, and compliance frameworks
- Track and close audit non-conformances
- Collaborate with stakeholders to ensure quality standards
- Conduct process trainings and quality initiatives
Required Skills
- Strong experience in Computer System Validation (CSV)
- Hands-on experience with QMS and SOP creation
- Certified ISO 9001:2015 and ISO 27001 Auditor
- Certified Scrum Master (Agile)
- Experience with URS, IQ/OQ/PQ, validation documentation
- Excellent MS Office and documentation skills
- Background in IT/Software industry (MNC preferred)
Eligibility Criteria
- BE / B.Tech / MCA (Regular only)
- 10+ years of experience in IT Quality / CSV domain
- Immediate to 60 days joiners preferred
- Only Delhi/NCR candidates (No Gurugram profiles)
Ideal Candidate
- Strong audit and compliance experience
- Detail-oriented with excellent communication skills
- Experience in pharmacovigilance or regulated environments is a plus
Pay: ₹2,500,000.00 - ₹3,000,000.00 per year
Benefits:
- Health insurance
- Life insurance
Work Location: In person
