Quality Systems Engineer (QAE) — CSV, GAMP 5 & 21 CFR

Lupin Ltd; New Jersey; In loco; USD 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

Lupin Ltd. is seeking an experienced Quality Engineer-CSV in New Jersey to administer and validate computerized Quality Systems across laboratory and manufacturing operations.

You will manage user roles, security, and audit trails while supporting Veeva Vault QMS, QualityDocs, and Training. The role emphasizes data integrity, risk assessment, and adherence to 21 CFR Part 11 and EU Annex 11 with a focus on process optimization.

Competenze

• Strong knowledge of GAMP 5, Annex 11, CSV, data integrity, and applicable FDA/EU requirements.
• Experience with Veeva Vault or similar electronic Quality Systems preferred.
• Strong analytical, troubleshooting, communication, and stakeholder-management skills.
• Hands on knowledge on Veeva, LIMS, ELN, SAP, and MES systems is preferred.
• 3-8 years of experience in Quality Systems, CSV, systems administration.
• Experience supporting laboratory, manufacturing, and/or enterprise computerized systems.

Mansioni

• Administer and support PLCs, SCADA systems, Windows-based applications, laboratory instruments, manufacturing systems, and enterprise applications.
• Support system administration activities including user/role management, security configuration, audit trails, backup/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/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 qualification (Installation, Operational, and Performance Qualification) reviews of 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, Data Integrity.

Conoscenze

GAMP 5

Annex 11

CSV

Data integrity

FDA/EU requirements

Veeva Vault

LIMS

ELN

SAP

MES

Analytical skills

Stakeholder management

Strumenti

Veeva Vault

LIMS

ELN

SAP

MES

Descrizione del lavoro

Lupin Ltd. is seeking an experienced Quality Engineer-CSV in New Jersey to administer and validate computerized Quality Systems across laboratory and manufacturing operations.

You will manage user roles, security, and audit trails while supporting Veeva Vault QMS, QualityDocs, and Training. The role emphasizes data integrity, risk assessment, and adherence to 21 CFR Part 11 and EU Annex 11 with a focus on process optimization.