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Computerized Systems Validation (CSV) Expert

Date: May 14, 2019

Location: Sofia, BG, 1407

Company: Teva Pharmaceuticals

Company Info

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs. We have an established presence in generics, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 45,000 professionals, committed to improving the lives of millions of patients. Learn more at www.tevapharm.com.

 

Since August 2016 Actavis has been part of Teva. In Bulgaria the combined company is working under the Actavis brand and is the largest employer in the pharmaceutical industry. Actavis - a Teva company - manages two manufacturing plants, sales and marketing organization and a number of global corporate functions.

 

We are searching for qualified and motivated candidates for the role of Computerized Systems Validation (CSV) Expert, who would like to join to the Global IT Quality & Compliance team.

The role

The position is based in Sofia. 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.

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

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 is considered an advantage
  • Knowledge of FDA, GxP and related regulations is considered an advantage
  • Strong project management skills with the ability to prioritize assignments
  • Excellent communication skills, team player
  • Excellent command of English

We offer

  • Dynamic and challenging work environment in the leading pharmaceutical company in the world and the biggest pharmaceutical company in Bulgaria
  • Competitive remuneration bound with performance
  • CSV onboarding training and knowledge transfer for 4 to 6 weeks
     
    If this sounds like the right opportunity for you, apply directly online through the button ‘Apply’ and send us your CV in English.
    All personal data is protected by law and will be treated in confidentiality.

Function

Information Technology

Sub Function

Business Process Analysis

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.