Teva Jobs

IT QA Manager

Date: Apr 5, 2024

Location:

Sofia, Bulgaria, 1407

Company: Teva Pharmaceuticals

Job Id: 54890

Who we are

As a global leader in generic medicines with a strong innovative portfolio, we are all in for better health.

Teva Pharmaceuticals has been developing and producing medicines for more than 120 years. Along with our established presence in generics, we have significant research and operations supporting our growing portfolio of innovative medicines and biopharmaceutical products.

Today, our portfolio of around 3,600 products is among the largest of any pharmaceutical company in the world. Nearly 200 million people in 60 countries benefit from one of Teva's quality medicines every day. We invest in research and development of innovative medicines, generic drugs and biosimilars, carrying on the legacy of more than a century of finding new ways to help patients improve their lives. This defines our values as a company and characterizes how we do business and approach medicine.

This defines how we do business and motivates thousands of Teva employees all over the world, every single day.

Learn more at www.tevapharm.com.

In Bulgaria Teva (known as Actavis until 2020) is the largest employer in the pharmaceutical industry with near 1700 employees in the two manufacturing plants (Dupnitsa and Troyan), sales and marketing organization and in a number of global corporate functions based in our country. We believe that each and every one of us should have access to quality medicines that help manage illness, fight infection or simply support overall health. Learn more at www.teva.bg.

We are searching for qualified and motivated candidate for the role of IT QA Manager , based in Sofia.

The opportunity

The main purpose of this role in the Global IT Quality and Compliance Department (IT Q&C), is to actively work on global IT projects on a manager level to provide guidance and support for validation and compliance of the 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. IT projects will be primarily in the area of R&D supporting business functions such as Pharmacovigilance, Clinical, Medical Affairs, Patient Services and Support, and Regulatory Affairs.

How you’ll spend your day

• Provide project validation support by assisting the creation and reviewing and approving all required validation deliverables from a Quality perspective

• Provide system life-cycle maintenance support by creating, reviewing, approving, and maintaining validation deliverables from a Quality perspective

• Support complex processes and new system implementations requiring a new perspective using existing solutions

• Actively contribute to extend and preserve the Computer Systems Validation (CSV) knowledge in the IT Q&C team and in the company

• Provide informal guidance to customers and team members when required (e.g. in project management, usage of policies, interpretation of regulations)

• Contributes to and/or leads process improvement programs in IT Q&C and issue solving by creating plans and deliverables, providing input and training.

• Resolves complex problems using existing solutions or providing new ones

• Leads large and complex projects, innovative system validation approach, or new innovative implementations requiring a new perspective using existing solutions.

• Works independently; receives minimal guidance

• Acts as a resource for colleagues with less experience and may formally train junior staff

• Leads the work of project teams providing project management guidance when required.

Your experience and qualifications

• Master’s or Bachelor’s degree

• Professional experience in CSV or SDLC activities in a regulated environment – minimum 5 years

• Experience in IT system implementation

• In-depth knowledge of GxP compliance requirements and guidelines to validation & compliance

• Specialized knowledge and experience in complex Computer System Validation.

• In-depth knowledge of GxP compliance requirements of the European Medicines Agency (EMA) and/or US Food and Drug Administration (FDA) EMA, US FDA and other international and national GxP regulations and guidelines to validation & compliance (i.e. GAMP5, 21 CFR Part 11, Eudralex Annex 11, etc))

• Knowledge of validation methodologies and Data Integrity (DI) principles

• A deep understanding of risk-based approach for validation and compliance activities

• In-depth working experience in CSV in a regulated environment

• Orientation to achieving results and attention to detail

• Strong interpersonal and communication skills

• Excellent cooperation, analytical and presentational skills

• Proven ability as a team player in an international work environment

• Excellent command of English

Enjoy a more rewarding choice

• Dynamic and challenging work environment in one of the world leading pharmaceutical company and the biggest pharmaceutical company in Bulgaria

• Competitive remuneration bound with performance

• Additional healthcare insurance

• Transportation allowance and other flexible benefits according to the company policy

• Flexible working hours and option to work from home as per the company policy

• Opportunity for development

Make a difference with Teva Pharmaceuticals

If this sounds like the right opportunity for you, send us your CV in English.

Please, kindly note that only shortlisted applicants will be contacted. All personal data is protected by law and will be treated in confidence.

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 (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)

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.

EOE including disability/veteran