IT QA Expert- Computer System Validation

3-5 years
2 months ago 10 Applied
Job Description

Who we are

Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

This section is where we attract the attention of potential candidates and sell the role. How has the role come about What makes it appealing What are the key responsibilities How is the role better with Teva than with another company Wherever possible, we should bring through the essence of our EVP pillars, i.e., we care, we're in it together, and we make work fulfilling.

How you'll spend your day

  • The role includes the following main responsibilities to support services offered by Global IT Quality and Compliance Operations department:
  • Provide project validation support by assisting the creation and reviewing and approving all required validation deliverables from Quality perspective
  • Provide system life-cycle maintenance support by creating, reviewing, approving and maintaining validation deliverables from Quality perspective
  • Actively contribute to extend and preserve the Computer Systems Validation (CSV) knowledge in the Global IT Quality and Compliance Operations team and in the company
  • Support the CSV continuous improvement opportunities and knowledge-sharing
  • The role also includes the following responsibilities to support services offered by the Global Quality and Compliance Operations department:
  • Provide local audit support
  • Support global supplier qualification process
  • Support procedures and guideline management
  • Support training management
  • Support inventory management
  • Support infrastructure qualification
  • Support IT Q&C process improvements

Your experience and qualifications

  • Master's/Bachelor's degree
  • Professional experience in CSV or SDLC activities and/or Quality Assurance (QA) or compliance activities in a regulated environment - at least 3 to 5 years
  • Experience in IT system implementation
  • A thorough knowledge of GxP compliance requirements of the European Medicines Agency (EMA) and/or US Food and Drug Administration (FDA) and other international and national GxP regulations and guidelines to validation & compliance
  • A deep understanding of risk-based approach for validation and compliance activities
  • Orientation to achieving results and attention to detail
  • Excellent command of English
  • Strong interpersonal and communication skills
  • Excellent cooperation, analytical and presentational skills
  • Proven ability as a team player in an international work environment

Reports To

Associate Director IT QA

Already Working @TEVA

If you are a current Teva employee, please apply using the internal career site available on Employee Central. By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:

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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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

JOB TYPE

Industry

Function

Skills

Csv
Qa
presentational skills
risk-based approach
GxP compliance requirements
IT system implementation
About
Job Source: careers.teva

Teva Pharmaceutical Industries Ltd. is an Israeli multinational pharmaceutical company with headquarters in Petah Tikva, Israel. It specializes primarily in generic drugs, but other business interests include active pharmaceutical ingredients and, to a lesser extent, proprietary pharmaceuticals.

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