JT001 - CSV/DATA INTEGRITY

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• System Audit Trail Review (SATR) and approval for the manufacturing/QC Laboratory area.
• Manage the validation of in-house projects for computer and automated systems for Laboratory, Sterile, Non-Sterile and Utilities/Facilities Operations
• Manage, execute Data Integrity Assessments for computerized systems 
• Manage and execute the Computerized Systems Periodic Review Program, including the periodic review of Data Integrity requirements for computerized systems.
• EBRs, Laboratory Analytical instruments upgrade initiative, and CSV IT Compliance activities including development of validation documents, routing, execution and all related CSV Lifecycle documents.

Qualifications:

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.
• Previous experience in computer system validation within the pharmaceutical or biotechnology industry.
• In-depth knowledge of GxP and FDA regulations.
• Strong technical documentation and project management skills.
• Excellent communication and teamwork abilities.
• Problem-solving skills and informed decision-making capability.
• 5-8 years of experience in CSV
• Experience in pharmaceuticals, medical devices or biopharma