QA Engineer (QAE)
About The Position
Lupin is seeking an experienced Quality Engineer-CSV to support the administration, validation, maintenance, and continuous improvement of computerized and electronic Quality Systems across laboratory, manufacturing, and Quality operations. The role supports systems ranging from PLCs, SCADA systems, Windows-based applications, laboratory instruments, and manufacturing systems to enterprise applications and electronic Quality Systems such as Veeva Vault QMS, QualityDocs, and Vault Training. The position includes system administration, end-user support, configuration and workflow improvements, Quality System metrics and KPI monitoring, computerized system validation (CSV), data integrity activities, and qualification reviews for laboratory instruments and manufacturing equipment. The Quality Engineer partners with Quality, IT, Engineering, vendors, and business users to troubleshoot issues and implement enhancements, while ensuring compliance with applicable FDA and EU requirements and standards.
Requirements
- Strong knowledge of GAMP 5, Annex 11, CSV, data integrity, and applicable FDA/EU requirements.
- Strong analytical, troubleshooting, communication, and stakeholder-management skills.
- 3–8 years of experience in Quality Systems, CSV, or systems administration.
- Experience supporting laboratory, manufacturing, and/or enterprise computerized systems.
Nice To Haves
- Experience with Veeva Vault or similar electronic Quality Systems.
- Hands-on knowledge of Veeva, LIMS, ELN, SAP, and MES systems.
Responsibilities
- Administer and support PLCs, SCADA systems, Windows-based applications, laboratory instruments, manufacturing systems, and enterprise applications.
- Perform system administration activities, including user and role management, security configuration, audit trails, backup and restore, reporting, and other system configurations.
- Provide end-user and operational support for Veeva Vault QMS, QualityDocs, Vault Training, and other quality systems.
- Maintain and improve electronic Quality Systems, including workflows, configurations, procedures, and system processes.
- Develop and monitor Quality System metrics and KPIs, identify trends, and present results and improvement opportunities to management.
- Identify opportunities to simplify, standardize, and improve the efficiency of Quality and computerized system processes.
- Perform CSV and data integrity activities, including risk assessments, URS, configuration specifications, testing/UAT, RTM, validation reports, periodic reviews, and SOP updates.
- Support reviews of Installation, Operational, and Performance Qualification for laboratory instruments and manufacturing equipment.
- Partner with Quality, IT, Engineering, vendors, and business users to troubleshoot issues and implement system enhancements.
- Ensure compliance with 21 CFR Part 11, 21 CFR Part 211, EU Annex 11, GAMP 5, and data integrity requirements.
Benefits
- Discretionary 7.5% performance bonus, based upon eligibility.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
