Specjalista Ds. Walidacji Systemów Komputerowych

Specjalista ds. Walidacji Systemów Komputerowych (7804)

**Career Opportunities: Specjalista ds. Walidacji Systemów Komputerowych (7804)**

Requisition ID **7804** - Posted - **EMEA** - **IT** - **PL-Rzeszów** - City (8)

Bausch Health Poland, part of Bausch Health Companies Inc. is a global firm that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.

Our approximately 21,000 employees are united around our mission of improving people’s lives with our health care products, and we manufacture and market health care products directly or indirectly in approximately 100 countries.

Currently we are looking for a person for the position of:
**IT Validation Specialist**

Place of work: RzeszówWarszawa, Jelenia Góra

**Computerized Systems Validation Specialist**

The Computerized Systems Validation Specialist will design and deliver documentation for IT systems to fulfill pharma related legal requirements.

This position is closely aligned with the Global Validation leadership and contributes to educate and deploy common practices across the EMEA region. As a complementary activity, contribution to change management activities according to priorities and availability related to required validation work.

**S** **COPE AND CORE RESPONSIBILITIES**
- Provide validation services for IT solutions.
- Perform IT Vendor Audit of IT solutions.
- Create, review documentation such as Standard Operating Procedures (SOPs), validation plans, user requirements specifications (URS), functional and design specifications (FS and DS), testing protocols (IQ/OQ/PQ), risk assessments, traceability matrices, validation reports, and change control documentation to support validation activities.
- Cooperate implementing CSV framework based on GAMP 5. (Good Automated Manufacturing Practice)
- Supporting training and document management of training records from IT and SOP systems and IT Instruction.
- Cooperation in the implementation of the validation process based on GAMP5. (Good automated manufacturing practice).
- Development and training of concerned business and IT team members on IT Validation procedures, in alignment with the Global Validation direction.
- Driving consistency in Validation processes across entire EMEA in close relation with the Corporate IT Validation leadership.
- Management, collection and protection of validation documentation regarding supervised systems, which could be the material necessary to manage, validate and audit the company's IT systems in the region.
- Collaboration with external service suppliers managing system changes and/or managing validation activities.
- As a complementary activity, contribution to change management activities according to priorities and availability related to validation work.
- Work collaboratively across functions within Quality, IT, Logistics, and Manufacturing.
- Support internal and external audits on systems in scope by providing information required by auditors that relates to IT SQA.

**EXPERIENCE AND SKILL SETS PREFERRED**
- Educated on GAMP 5, Annexes 11 and 15 of the EU GMP and FDA Part 11.
- Experienced on validation and audits on GxP IT systems.
- Knowledge of IT technologies related to production and distribution processes in the pharmaceutical industry.
- Excellent communicator with the ability to work at all levels
- Experience working in Europe in different cultures
- Project coordination skills
- Positive attitude and longing for results are essential qualities
- Analytical and creative, able to offer new ideas and perspectives to the situation
- Flexible approach to working hours and location
- Ability to work as part of a dispersed team but also self-motivated
- Broad experience of IT solution.
- Ability to perform and conduct workshops and meetings to develop solutions
- Fluent in Polish and English.

**WE OFFER**:

- Stable employment in a modern and dynamically developing global pharmaceutical company,
- Salary reflecting competence and performance,
- Wide range of a career development,
- Rich benefits package.

Bausch Health is an EEO/AA employer M/F/D/V.