Key Requirements :
Candidates must have prior experience in the healthcare industry (Pharma/Biotech).
Software Testing/Automation Testing profiles are not suitable .
Synopsis:
The Senior/Lead Software Quality Engineer ensures validation projects comply strictly with 21 CFR Part 11 requirements , encompassing validation, data integrity, cybersecurity, periodic reviews, change management, CAPAs, and audit support. This role is compliance-focused, acting as the division's SME for non-product software lifecycle policies and procedures.
Key responsibilities include reviewing software activities (e.g., supplier evaluations, lifecycle documentation) to ensure alignment with procedures, standards, and regulatory requirements, as well as overseeing multi-site and division-wide software lifecycle activities. Frequent interaction with senior management is required.
Minimum Qualifications
- Education :
- Bachelor’s degree with 8+ years of experience, or
- Master’s degree with 5+ years of experience.
- (Graduation year must be included on resumes.)
Top 5 Skills/Requirements
- Experience in Regulated Industry : Familiarity with GxP systems.
- Regulatory Knowledge : Deep understanding of FDA regulations (21 CFR Part 11, 820, Annex 11), GAMP5, ISO 13485, and ISO 27001.
- Quality & Test Management Tools : Proficiency with systems like TrackWise, ComplianceWire, Veeva, ALM, JIRA, etc.
- Data Integrity and Audit Support : Prior experience supporting internal and external audits.
- Software Expertise : Hands-on experience with SaaS, IaaS, PaaS, COTS, and custom applications.