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.
Essential Duties and Responsibilities:
- Lead Qualification and Validation projects, to ensure new equipment and processes are operational on time and existing equipment and processes remain in a validated state
- Preparation of validation documents / protocols (VMP’s, URS, RTM, DQ, IQ, OQ & PQ)
- Execution of Validation activities
- Adhere strictly to regulatory, cGMP, Standard Operating Procedures, Policies & any other rules defined by the Company
- Ensure site Validation Master Plan (sVMP) is maintained and activities listed within are actioned in a timely manner.
- Deviation / Non- Conformance management (Including RCA & CA/PA)
- Change Control Management
- Identify opportunities and propose justified solutions for productivity improvements, including automation of manual processes and the use of IT-systems; and to manage their implementation
- Support the CPI and CQI programmes by training and facilitation of teams
- Maintain and develop a suite of Metrics and KPIs, to provide direction and reporting information for teams and management in the area of Validation.
- Participating in and contributing to Baxter team projects and initiatives as required
- Partaking in regulatory, corporate and internal audits as required & ensuring validation documents are in a state of “audit readiness”.
Qualifications :
- Basic Science, Engineering or Pharmacy qualification
- Demonstrate knowledge and understanding of the requirements of the position
- Project Management experience
- Hands-on experience in pharmaceutical aseptic production
- Experience in 6-Sigma and Lean Manufacturing
- Demonstrate skills in problem-solving, system design, application of technological and business tools and the use of IT systems
- Logical, practical-minded with a hands-on approach
- Creative, analytical, innovative,
- Self-motivated and able to motivate others
- Shows good judgment to achieve a balance between cost: benefit, quality and safety
- Able to communicate effectively, written and oral
- Able to manage effectively resources and time
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 Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
