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Senior Computer Systems Validation Associate | Pune

TransPerfectPune, Mahārāshtra, India
On-site Full-time

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Experience Level

Experience

Qualifications

REQUIRED SKILLSIn-depth knowledge of e-Clinical technologies. Commitment to adhering to TransPerfect’s high-quality standards. Exceptional problem-solving and critical thinking skills with a fast learning curve. Strong organizational and multitasking capabilities to meet deadlines. Excellent written and verbal communication skills in English. Proficient in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint). EXPERIENCE AND QUALIFICATIONSBachelor's degree in Life Sciences, Information Technology, Engineering, or a related field, or equivalent experience.2-4 years of relevant experience in Computerized System Validation within the Life Sciences sector. Familiarity with study documentation related to clinical development.

About the job

The Senior Computer Systems Validation (CSV) Associate at TransPerfect is pivotal in ensuring compliance with 21 CFR Part 11 and GCP/ICH regulations within our Life Sciences division. This role is instrumental in upholding the integrity of our ISO 9001 certified Quality Management Systems across all computerized systems. As a key member of our QA team, you will report directly to the QA Manager, taking an active role in CSV activities, mentoring junior associates, and collaborating with cross-functional teams to achieve project objectives.

KEY RESPONSIBILITIES

  • Execute the corporate Quality Management Systems (QMS) specifically focused on Computerized Systems Validation within the Trial Interactive division, covering:

• Software Development Life Cycle
• Validation of Commercial off-the-shelf (COTS) products and third-party Supplier Qualification
• Infrastructure qualification
• Regulatory compliance assessments
• Validation package assessments
• Operational readiness checks
• Periodic system reviews
• Change control processes

  • Investigate validation-specific issues and operational challenges to determine root causes and implement corrective actions.

  • Assist the QA team in drafting formal Client Escalation Reports.

  • Enhance knowledge of Systems Validation processes among colleagues through training and other engagement methods.

  • Mentor and train junior team members.

  • Complete other tasks as assigned by your supervisor.

About TransPerfect

TransPerfect is a leading provider of language and technology solutions for the Life Sciences industry. Our commitment to quality and regulatory compliance makes us a trusted partner for clients across the globe. We prioritize innovation and excellence in every project, ensuring that our systems are not only compliant but also optimized for performance.

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