Description

Lead quality assurance and validation for biopharmaceutical facilities, utilities, and manufacturing environments under FDA regulations.

This role is on-site.

Responsibilities

• Lead software design, testing, and qualification of GMP equipment.
• Manage the SDLC for Quality Control equipment using HP-ALM.
• Prepare, maintain, and review validation and compliance documentation.
• Analyze validation test data to ensure systems meet required criteria.
• Identify deviations, recommend resolutions, and manage CAPA reports.

Required Skills

• BS or foreign equivalent in CS, IT, Engineering, IS, Science, or related field with 5+ years of progressive experience.
• MS or foreign equivalent in CS, IT, Engineering, IS, Science, or related field with 3+ years of experience.
• Experience with HP ALM, Veeva Quality, eTMF, RIM, and Suvoda.
• Proficiency in SharePoint, SAP ECC, Toad, and JIRA.
• Technical knowledge of SQL, MS Visio, and PLC/SCADA.
• Experience with CARA and regulatory standards including EU Annex 11, PIC/S Guide, CFR 820, CFR 210, and CFR 211.

Key Skills

Education

Any Graduate