Computerized Systems Validation (CSV) Expert
Parsippany, NJ

Job Description

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

The role

The position of Computerized Systems (CS) Validation Expert is based in Parsippany, NJ. Its main purpose is to provide guidance and support for Computerized Systems Validation (CSV) and compliance issues in the process of the System Development Life Cycle (SDLC), review and approve all required deliverables. Organizationally it is part of the Global IT Quality & Compliance department.

Main duties and responsibilities

* Provide guidance and support for validation and compliance aspects of the computer systems
* Review and approve IT project documentation from Quality Assurance (QA) perspective - user requirements and other specifications, test protocols
* Create and maintain the validation strategic deliverables - validation plans and reports
* Support global supplier qualification process
* Support IT Q&C process improvements
* Support Computerized Systems inventory management

Qualifications

Successful candidates should have

* Experience in performing QA activities or writing, reviewing and approving documentation in a Quality Management System (QMS) or ISO regulated environment
* Computerized Systems Validation (CSV) and IT compliance experience
* Knowledge of FDA, GxP and related regulations
* Strong project management skills with the ability to prioritize assignments
* Excellent communication skills, team player
* Excellent command of English

Function

Information Technology

Sub Function

Business Process Analysis

Reports To

Senior Manager IT QA and Testing, IT Quality & Compliance Global Operations (BG)

Teva's Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

Nearest Major Market: New York City

Nearest Secondary Market: Newark