Description

You will provide technical leadership for quality assurance and validation across biopharmaceutical facilities, utilities, laboratories, and manufacturing environments.

Responsibilities

• Lead software design, testing, and qualification of GMP equipment under FDA regulations.
• 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 and processes meet required criteria.
• Develop and maintain databases for tracking test results, validation activities, and validated systems.
• Identify deviations, recommend resolutions, and manage CAPA reports.

Required Skills

• 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.
• MS or foreign equivalent in Computer Science, IT, Engineering, IS, Science, or a related field with 3 years of experience in quality control, compliance, and system validation using HP ALM.
• BS or foreign equivalent in Computer Science, IT, Engineering, IS, Science, or a related field with 5 years of progressive experience in quality control, compliance, and system validation using HP ALM.

Key Skills

Education

Any Graduate