- Plan, organize, manage, co-ordinate ad control through collaborators the quality assurance activities in plant environment in order to provide products and systems that meet the customer requirements and global regulatory requirements and ae consistent with the Quality Policy of the company and the Quality Policies.
- Represent the Quality Management System and ensure that the requirement of the ISO 9001, 13485 and GMP's are implemented and maintained.
- Be responsible for the Quality Assurance / Control function of the manufacturing site.
- Ensure that processes needed for the Quality Management System are established, implemented and maintained.
- Report to management on the performance of the Quality Management System and need for improvements.
- Ensure the promotion of awareness of regulatory and customer requirements throughout the organization.
- Manage the plant QA function to ensure that all product comply with customer and regulatory requirements and Company Quality System System Standards.
- Evaluate trough routine internal audits if all systems are well maintained in order to avoid potential alteration of products and process, and quality management system.
- Respond to complaints from the market place using internal quality indicators and batch files.
- Perform additional testing as required and consult with R&D on design related complaints.
- Ensure the follow up of the SOP and protocols related to product and process changes required.
- Prepare and manage the annual budget for Quality Assurance department in the plant.
- Determine the disposition of in process or finished goods produced under abnormal conditions.
- Ensure that products are released in a timely manner such that a constant supply is available to our customer.
- Ensure conformance to Corporate and statutory GMP throughout the facility.
- Ensure necessary improvements in the product quality data the plant executive team to priorities CAPA's and achieve necessary improvements in the product quality.
- Lead the site Quality Management review process.
- University – 5 years : Science / Engineering
- 10 + years of experience in Quality Management Systems and Quality Manufacturing Operations
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Plant Quality Director - Lessines, België - Baxter
Beschrijving
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:Essential Duties and Responsibilities:
Requirements:
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