Computer Systems Validation Specialist | Pune
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Job Location:
Monthly Salary:
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
Job description
OVERVIEW
The Computer Systems Validation (CSV) Specialist Trial Interactive reports to TransPerfects Director QA & systems Validation Trial Interactive and impacts all aspects of TransPerfects 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:
o Software Development Life Cycle
o Commercial off the shelf (COTS) Validation and subsequent 3rd Party Vendor Qualification
o Infrastructure Qualification
o Regulatory Compliance Evaluations
o Validation Package Reviews/Approvals
o Operational Readiness
o Periodic Reviews
o Change Control
o 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
Job requirements
REQUIRED SKILLS
Experience with study documentation for clinical development
Knowledge of eClinical technologies
Ability to adhere to and abide by the clients and companys 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 Bachelors 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
- Pune Mahārāshtra India
All done!
Your application has been successfully submitted!
Required Experience:
IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
TransPerfect Translations is a translation, E-Discovery and language services company based in New York City. The company serves clients in many fields, such as film, gaming, legal and healthcare fields. As of 2012, TransPerfect is "the largest privately owned language services provid ... View more
