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IT QA Lead Expert - Quality & Manufacturing Systems

Teva Pharmaceutical Industries
On-site
Croatia
QA Lead

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

The primary purpose of this role within the Global Operations unit of the Global IT Quality and Compliance (IT Q&C) department is to provide expert-level support for validation and compliance activities related to computerized systems, with a focus on Quality Control (QC) systems (e.g., LIMS, Empower) and Electronic Document Management Systems (EDMS). The role involves working alongside IT project teams to guide and oversee validation efforts throughout the System Development Lifecycle (SDLC), ensuring alignment with applicable regulatory requirements, internal standards, and procedures.

How you’ll spend your day

The role includes the following responsibilities to support services offered by Global Operations:

  • Provide validation support for IT projects by reviewing and approving validation deliverables from a Quality perspective, including specifications, test plans, test results, and change controls.
  • Support system lifecycle activities by creating, reviewing, and maintaining validation documentation in compliance with GxP and internal standards.
  • Ensure data integrity (ALCOA+) is embedded in system design, implementation, and operation.
  • Collaborate with IT, Quality, and Business stakeholders to ensure alignment on validation and compliance expectations.
  • Support complex system implementations and upgrades, applying a risk-based approach to validation and compliance.
  • Contribute to the development and maintenance of validation procedures, templates, and strategic documentation.
  • Provide informal guidance and training to project teams and stakeholders on validation practices, regulatory expectations, and internal policies.
  • Actively contribute to the continuous improvement and knowledge sharing within the IT Q&C team and across the organization.

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The role also includes the following responsibilities to support services offered by the IT Q&C department:

  • Support internal and external audits (regulatory, customer, supplier) and ensure audit readiness.
  • Contribute to the global supplier qualification process by reviewing validation and compliance documentation.
  • Support the management and maintenance of procedures, guidelines, and training materials.
  • Assist in infrastructure qualification and inventory management activities.
  • Participate in IT Q&C process improvement initiatives.

Your experience and qualifications

  • Bachelor’s or Master’s degree in Information Technology, Life Sciences, or a related field.
  • Minimum of 3 years of professional experience in Computer System Validation (CSV) or SDLC activities in a GxP-regulated environment.
  • Experience in IT system implementation, particularly in QC and EDMS domains.
  • In-depth knowledge of GxP compliance requirements from EMA, FDA, and other relevant regulatory bodies.
  • Strong understanding of risk-based validation and compliance approaches.
  • Proven experience in CSV within regulated environments.
  • High attention to detail and results-oriented mindset.
  • Excellent command of English (written and spoken).
  • Strong interpersonal, communication, and presentation skills.
  • Ability to work effectively in a global, cross-functional team environment.

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: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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.
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