BAXTER Hiring For Validation Specialist – FTC at Dublin, County Dublin Full Time

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.

To maintain the Site Validation Master Plan and to provide a service to the local site for the validation of new and existing processes/equipment/systems by developing and maintaining plans providing visibility of key validation requirements.

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

“What are some of our benefits of working at Baxter?

Pension

Health Insurance

Life Assurance

Baxter is committed to growing and developing an inclusive and diverse workforce – you can read more about our specific values here https://www.baxter.com/careers/inclusion-diversity.

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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.

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.

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