The IT QA-CSV Analyst primary function is to make sure all computerized and automated systems of manufacturing equipment are IT/CSV compliant with respect to all regulatory requirements. The Person is the primary point of contact for all IT support during regulatory agency and third-party inspection.
• Supports implementation of AVET’s IT Processes, CSV Principles and related regulatory system validation requirements for manufacturing applications with respect to 21 CFR Part 11 guidelines
• Ensure User management and User administration for QC/QA and Mfg. computerized and automated systems and Enterprise applications
• Create, execute and review protocols (IQ/OQ/PQ) collaboratively with respective user departments (QC) for all IT manufacturing and Quality management systems
• Assists with managing Quality Management systems (Trackwise, LIMS, DMS) troubleshooting system configuration issues, preparing and managing quarterly releases.
• Escalates application or system related issues to application owner and vendor
• Supporting in the auto data backup and manual data backup for computerized and automated systems
• Drive and participation in FAT (Factory Acceptance Test) and SAT (Site Acceptance Test) for related manufacturing systems/equipment.
• Ensure timely support in troubleshooting, review activity and audits for computerized and automated systems of manufacturing equipment.
• Handling and Manage Regulatory, Customer and Internal audits related to data backup and restore and user management and ensure compliance
• Support during periodic review and periodic data restoration activity
• Execution admin related of activities of IT manufacturing and Quality management systems
• Review of protocols/reports for all CSV documents as per life cycle SOP for IT mfg, QC and Enterprise GMP applications.
• Control and issuance management of all IT SOP, Formats, Protocols, reports and other documents.
• Define and implement Quality Management System policies, implementation Standards, training content and methodology
Specialized Skills and Knowledge:
• Bachelor’s Degree in Life Sciences/Electrical Engineering
• Minimum of 5 years’ experience in life science/related industry
• In-depth understanding of industry-accepted software development and validation life cycle programs and related IT controls
• Validation protocols (IQ/OQ/PQ) generation and execution of manufacturing and laboratory equipment
• GMP/Validation experience required
• Strong customer service orientation.
• Operate effectively and with minimal supervision, within a team or independently, performing special projects and related duties, as assigned
• Identify opportunities for continuous improvement.
Sufficient mobility to perform duties in small spaces involving crouching, stooping, kneeling and physical ability to perform tasks requiring physical strength to lift 30-45lbs
Avet is proud to be an Equal Opportunity Employer.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs