This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary

The role will be managing and supporting the documentation and training elements with the Management control Entity in the EMEA business units, including all sub-entities and the manufacturing sites reporting into the region.

The role will be required to:

• Manage and support the deployment of the Quality Systems via the Documentation and Training processes within the EMEA solutions and Device Business Units.
• Supports the EMEA management control entity and EMEA sites during inspections in relation to training and documentation
• Act as the SME for TcU and BaxU for EMEA.
• Documentation support for EMEA/BHSA/CQA
• Training support for EMEA/BHSA/CQA
• Be the CS3 for BHSA
• Be an SME on Paper Data integrity

Essential Duties and Responsibilities. 

1. Manage and support the Documentation and Training Process:

Coordinate and work with SME's (subject matter experts) and or EEELs (EMEA entity element leads) for Entity Reviews and Impact assessments for new and revised procedures (Global, regional and local) Manages and executes the tasks required as specified in the Implementation Assessments as regards to any impacted documents and/or Training Modifications for employees required at both Regional and Entity level. Draft and provide mark-ups of regional documents as required.

2. Support the management of Training process and training records as needed

Support the maintainance of  the Training process, including Training curricula, new training, re-training and training package management. b.Support in Identification of training needs for entity employees Acts as the EMEA Learning professional for BaxU to support the EMEA Management Control Entities.

3. Creates, revises, publishes and obsoletes EMEA QS Documentation in TcU as required.

a. Acts as Regional Coach for TcU with high knowledge and expertise of the system

4. Support external audits at the respective location/entity

a. Ensure the follow up and closure of the action plans identified during external assessments.

5. Trend, analyse and compile reports for key metrics within the Region.

6. Participate in QS improvement projects as needed. Implement continuous improvement attitude through lean initiatives in practice by Baxter.

7.  Support the CAPA, Change control and Management review processes in the region.

Qualifications. 

Post-Secondary Education.

Education and/or Experience. 

• Minimum of 2 years experience in Quality Systems/Documentation in a Pharmaceutical or Medical device related Industry.
• Excellent level of English (Spoken, Read, Written).
• Use of Word/Excel/Power Point is a must
• QS processes knowledge and experience (particular experience in documentation and training)
• Have a pragmatic approach, hands-on attitude.
• Ability to work in an international and matrix environment with different tasks
• Results oriented with a process and quality driven approach
• Self-driven with the ability to work independently as needed
• Excellent team-work and collaboration skills
• Strong communication skills: needs to cascade information both ways and ensure consistent, concise, clear messages to all, influence others skills
• Eagerness to learn, strong motivation
• Positive approach, optimism

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

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