Validation and Critical Systems Manager

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.

About the role

As Validation and Critical System Manager you manage the Sterile Drugs and Plastic equipment qualification and process validation activities in compliance to cGMP requirements and maintain the processes in an accurate validated state. You also manager the validation activities of computerized systems, Electronics Records and Electronics Signature in compliance with Corporate and legal requirements as well as the calibration of site instruments.

You Act as a Quality function for QC activities and Critical Systems of the site and Supervise the validation and calibration teams

What you will be doing

• Develop and deploy the Sterile Drugs and Plastics validation strategy and approach and assure compliance of internal validation procedures with corporate and regulatory standards. 

• Manage the Sterile Drugs and Plastics equipment qualification, process validation and computerized system validation activities and assure compliance with internal procedures.

• Provide validation expertise, support and quality assurance guidance for the implementation and maintenance of the validated state of production processes.

• Provide support for the implementation of new raw materials and pharmaceutical formulations in terms of validation.

• Provide support to the regulatory affairs group for file submissions.

• Approve as a FQA the validation documents

• Manage the calibration activities and assure compliance with internal procedures.

• Approve as a quality function the QC equipment qualification and requalification and assure compliance with internal procedures.

• Approve as a quality function the NCR/CAPA and Change Control Requests.

• Drive Continuous improvement in the team.

• Participate in internal and external audits as quality representative.

• Manage validation and calibration budgets and resources.

• Ensure training is completed for the department.
• Participate in internal audits and external quality system audits conducted by the Corporate or regulatory agency representatives.
• Perform reporting of KPI as applicable (CAPA review Board, Management Review…)
• Assure EMS/ 6S implementation and continuous improvement
• Respect allocated budget for the department
• Retain, motivate, train and follow up performance of direct reports.
• Define, monitor and continuously improve processes using appropriate KPI’s and Metrics in area of responsibility.

Your Profile

• Master’s degree or equivalent in chemistry, engineering, pharmaceutical sciences or related scientific field is required.
• Minimum of 5 - 10 years of experience in a role related to Quality : Equipment qualification & process validation, product development and people management in the pharmaceutical or medical device industries
• Minimum 3-5 years’ experience managing people.
• You have experience of leading a team of experts and enjoy supporting, mentoring, and developing team members.
• Delivers dedicated timelines.
• Excellent written and verbal communication, presentation, and facilitation skills·
• Practical experience with EU and FDA regulations and cGMP
• Good knowledge of validation practices (equipment qualification, processes validation and computerized systems validation)
• Influence management skills; demonstrated ability to work constructively across all functions of the organization, including customers and suppliers
• Excellente communication and presentations skills (articulate and persuasive)
• Strong team management and leadership skills. Ability to create strategies, define and articulate clear role expectations and direction. Willingness to do what it takes, including direct auditing activities at times.
• Sound organizational and multi-tasking skills.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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