Computer Systems Validation Specialist

OVERVIEW

The Computer Systems Validation (CSV) Specialist, Trial Interactive reports to TransPerfect’s Director, QA & systems Validation, Trial Interactive and impacts all aspects of TransPerfect’s Life Sciences 21 CFR Part 11 and GCP/ICH compliance, as well as the latest ISO 9001 standard certified quality management systems worldwide. The CSV Specialist, Trial Interactive plays a vital role in ensuring that computerized systems are developed, tested, released, and maintained in a validated state.

DESCRIPTION

• Responsible for the continued compliance and further expansion of the TransPerfect corporate Quality Management Systems (QMS) in the area of Computerized Systems Validation within the Trial Interactive division and consulting to other TransPerfect divisions as needed. This includes, but is not limited to, the following areas:

1. Software Development Life Cycle
2. Commercial off the shelf (COTS) Validation and subsequent 3rd Party Vendor Qualification
3. Infrastructure Qualification
4. Regulatory Compliance Evaluations
5. Validation Package Reviews/Approvals
6. Operational Readiness
7. Periodic Reviews
8. Change Control
9. Client-specific Validation Services

• Investigate validation specific complaints or adverse experiences and operational problems to identify root cause and effective corrective and preventive actions; provide the formal Client Escalation Report back to the client
• Actively maintain and improve colleagues’ awareness of Systems Validation processes, policies, and procedures through training and any other methods
• Travel up to 20% domestically and internationally as required
• Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor

REQUIRED SKILLS

• Experience with study documentation for clinical development
• Knowledge of eClinical technologies
• Ability to adhere to and abide by the client’s and company’s quality standards
• Exceptional problem solving/critical thinking skills and ability to learn new skills quickly
• Superior organizational and multi-tasking skills in order to meet commitments and deadlines
• Superior written and spoken communication skills in English
• Proficiency in Microsoft Office (Word, Excel, Outlook Powerpoint)

REQUIRED EXPERIENCE AND QUALIFICATIONS

• Minimum Bachelor’s Degree or its equivalent
• Minimum of 2 years of experience in the Life Sciences industry
• Minimum of 3 years of experience in the Computerised System Validation

DESIRED SKILLS AND EXPERIENCE

• Knowledge of the latest ISO 9001 and ISO 27001 standard
• Knowledge of clinical development phases and processes
• Knowledge of regulations (e.g. FDA, EMA, MHR) and industry best practices including GxP (e.g. GCP, GMP, GDP), ICH E6 R2, 21 CFR Part 11, Annex 11, GAMP 5.
• Previous employment in Pharmaceutical, CRO, Medical Device, or Investigative Site
• Previous experience in CAPA management and root cause investigations
• Fluency in a foreign language
• Able to multitask in a fast-paced environment
• Work well with people from a variety of different backgrounds and cultures
• Build relationships with clients and co-workers
• Can work independently and as part of a team