What are the responsibilities and job description for the Quality Engineer – CSV & Quality Systems position at QvalFocus Inc.?
We are seeking a Quality Engineer with experience in computerized systems validation and quality oversight within regulated pharmaceutical/life sciences environments. The role will support Quality Information Systems Management (QISM) initiatives across Manufacturing and Analytical Laboratory systems.
Key Responsibilities:
- Provide quality oversight for enterprise and lab system projects including ServiceNow, QMS, ERP, Veeva, RIM, Manufacturing, and Lab Systems
- Support system validation activities including requirements, risk assessments, test scripts, execution, and traceability reviews
- Participate in change controls, deviations, CAPAs, periodic reviews, and system releases
- Ensure compliance with Data Integrity, GAMP5, and validation lifecycle
- requirements
- Collaborate with cross-functional teams to resolve quality and compliance issues
- Identify quality risks and support mitigation planning
Required Skills:
- 6–10 years of experience in CSV/CSA, Quality Systems, or Validation
- Strong knowledge of GAMP5, Data Integrity, ITIL, and SDLC/validation lifecycle
- Experience with enterprise systems, manufacturing systems, and lab applications
- Strong documentation, analytical, and communication skills
Preferred:
- Experience with Veeva VQMS, ServiceNow, ALM/e-signature systems
- Knowledge of Agile validation methodologies
- Bachelor’s degree in IT, Computer Science, or related field