Virscio is seeking a Quality Assurance Auditor of Computerized Systems to support the QA Unit, Computer Systems Validation Unit and Testing Facility Management (TFM) in ensuring organization activities conform with Good Laboratory Practices (GLPs) and best practices stipulated in company Standard Operating Procedures (SOPs). The QA Auditor of Computerized Systems is responsible for ensuring computerized systems employed by Virscio are implemented and maintained in compliance with internal and external controls and regulations. This role supports system vendor qualification and audits, deviation/noncompliance investigations, CAPA implementations, and audit of documentation for computer system validation as it pertains to new system implementations, change control, periodic review, and system decommissioning. In addition, this role may support other QA deliverables in coordination with the QA Unit.
· Perform QA on assigned computerized system projects and advise on best practices/ documentation for computer system validation per current applicable regulations, guidances, and industry standards.
· Provide guidance and perform QA audits on system validation plans and protocols, risk assessments, traceability matrix, test plans, test execution and validation reports.
· Lead and conduct audits of computerized system vendors, defining the nature of the audit (e.g., paper, physical, etc.), time schedules, vendor contact(s), audit expectations; and following the audit, write the audit report to include all follow-up actions and establish a schedule for re-audit if required.
· Support audits conducted by clients and/or potential clients. Client audit responsibilities shall include adherence to audit expectations, and following the audit, supporting the response to the audit report including definition and/or support of all follow-up actions.
· Support, or lead where directed, deviation and CAPA investigations resulting from SOP deviations, validation plan/protocol execution deviations, or other noncompliance.
· Contribute to the creation and maintenance of quality-related policies and procedures to ensure that they remain up to date and aligned with current best practice for the discipline and government regulations.
· Provide subject matter expertise to lead and direct current practices and interpretation of local and international regulations as applicable to computer system validation in the life science industry. This includes FDA 21 CFR Part 11 and 21 CFR Part 58 in the U.S. and the equivalent international regulations and guidelines.
· Support maintenance of the Quality Management System (QMS), with a focus on continuous improvement.
· Requires bachelor’s degree in a life sciences or computer sciences area or comparable experience.
· At least 2 years of relevant GLP QA auditing experience, including computer system validation in the Bio-Pharmaceutical industry working in accordance with GLP regulations, 21 CFR Part 58.
· A sound working knowledge of the pharmaceutical business processes for R&D and GLP laboratories.
· Understanding of software development, implementation, remediation, and planning through full System Development Lifecycle (SDLC).
· Solid understanding of computer systems compliance to FDA and other government regulations (GLP and 21 CFR Part 11) as well as processes governing data information, privacy, and security.
· Excellent verbal and written communication skills. This role is responsible for facilitating project reviews with executive management as well as escalating and negotiating solutions when issues arise.
· Experience assessing risk and applying risk-based rationale to project and quality assessments.
· Ability to prioritize tasks effectively and meet project timelines.
· Collaborative in a team environment but also confident learning and working independently.
· Motivated self-learner, remaining effectively informed on changes in regulations and guidance that would impact Virscio’s defined standard practices.
· Demonstrated ability to adapt to the necessities of fast-paced research activities.
· Attention to detail and ability to identify and resolve issues effectively.
· Strong interpersonal skills and comfort interacting with Management, Computer Systems Validation Unit, Information Technology staff, Research team and Sponsors through various modes of communication.
· Strong computer literacy.
· Demonstrated ability to think critically.
· Ability to travel (<10%) in support of responsibilities.
New Haven, Connecticut, USA, St. Kitts, West Indies, or remote with appropriate qualifications.
Full-time or contract (6-12 month)
Virscio offers a competitive, flexible, and comprehensive benefits package that can be customized to fit your personal needs. Virscio’s benefits offering is designed to support the holistic wellbeing of our employee community and their families by providing affordable healthcare related coverages, retirement savings plan with immediate vesting, and a wide range of voluntary benefits for financial protection and peace of mind. Additionally, we offer a Culture of CARE where your health, well- being and gratification in career pursuits is our top priority.