Job Description

The Senior Computer Systems Validation (CSV) Associate, Trial Interactive, is responsible for supporting TransPerfect's Life Sciences 21 CFR Part 11 and GCP/ICH compliance and helping to maintain the certified ISO 9001 Quality Management systems across all computerized systems. This role ensures that TransPerfect’s computerized systems are developed, validated, and maintained in a state of compliance with regulatory requirements. Reporting to the QA Manager, the Senior CSV Associate, Trial Interactive takes on an active role in supporting CSV activities, mentoring junior associates, and engaging with cross-functional teams to meet project goals.

• Responsible for executing the TransPerfect corporate Quality Management Systems (QMS) in the area of Computerized Systems Validation within the Trial Interactive division. This includes, but is not limited to, the following areas:

o Software Development Life Cycle

o Commercial off-the-shelf (COTS) validation and subsequent third-party Supplier Qualification

o Infrastructure qualification

o Regulatory compliance evaluations

o Validation package reviews

o Operational readiness

o Periodic reviews

o Change control

• Investigate validation-specific complaints or adverse experiences and operational problems to identify root causes and effective corrective and preventive actions

• Support the QA team in writing 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

• Help mentor and train junior team members

• Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor

Requirements

REQUIRED SKILLS

• Knowledge of e-Clinical technologies

• Ability to adhere to and abide by the TransPerfect’s quality standards

• Strong problem-solving/critical thinking skills and ability to learn new skills quickly

• Strong organizational and multi-tasking skills to meet commitments and deadlines

• Strong written and spoken communication skills in English

• Strong proficiency in Microsoft Office (Word, Excel, Outlook PowerPoint)

REQUIRED EXPERIENCE AND QUALIFICATIONS

• Bachelor's degree in Life Sciences, Information Technology, Engineering, or a related field, or its equivalent

• Minimum of 2-4 years of experience in Computerized System Validation in the Life Sciences industry

• Experience with study documentation for clinical development

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 experience in CAPA management and root cause investigations

• Fluency in a foreign language

• Work well with people from a variety of different backgrounds and cultures

• Build relationships with co-workers

• Can work independently and as part of a team