IT QA Expert

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 main purpose of this role in the Global Operations unit at the Global IT Quality and Compliance Department (IT Q&C), is to work on IT projects to provide guidance and support for validation and compliance of R&D (Clinical, Regulatory Affairs, Medical Affairs, Patient Services Support, Pharmacovigilance, and Digital Health) related computerized systems in the process of the System Development Lifecycle (SDLC), and to review and approve all required validation deliverables by following applicable policies, standards and procedures. 

Main Responsibilities

• Provide project validation support by assisting the creation and reviewing and approving all required validation deliverables from Quality perspective for R&D systems
• Provide system life-cycle maintenance support by creating, reviewing, approving and maintaining validation deliverables from Quality perspective for R&D systems
• Actively contribute to extend and preserve the Computer System Validation (CSV) knowledge in the IT Q&C team and in the company
• Support the IT Q&C Operations by continuous improvement opportunities and knowledge-sharing
• Provide local and global 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

 

Within the scope of his responsibilities the employee:

• Generally, works under moderate or minimal supervision, the employee requires a low level of guidance and leadership
• Independently applies the basic concepts, procedures and practices in his/her area of expertise
• Carries out more diverse and complex tasks under guidance, but in these cases the employee's responsibility is limited
• Independently handles simple problems using standard procedures and is competent to suggest a solution for more complex problems

Qualifications

• Master’s or Bachelor’s degree
• At least 2-4 years Professional experience in CSV or SDLC activities and/or Quality Assurance (QA) or compliance activities in a regulated environment
• Experience in IT system implementation 
• Experience with R&D systems (i.e. Pharmacovigilance, Clinical, Medical Affairs, and/or Regulatory Affairs) preferred but not required
• 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 English speaking, reading, and writing skills
• Strong interpersonal and communication skills
• Excellent cooperation, analytical and presentational skills
• Proven ability as a team player in an international work environment

Function

Already Working @TEVA?

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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.