Teva QA Manager 

Bulgaria, Sofia 

315406677

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.

• 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.

• 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

• 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

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

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