Quality Associate II

Vantive: A New Company Built on Our Legacy
Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed sale of Vantive to funds managed by the Carlyle Group is subject to receipt of customary regulatory approvals and satisfaction of other closing conditions.

Summary :

Ensure Quality Assurance for the successful completion of new and improved product design and implementation projects within boundaries of quality, time and budget. Implement and maintain the Quality System to ensure compliance with the requirements of authorities and internal customers for drugs and medical devices.

Essential Duties and Responsibilities:

• Ensure Quality System processes are correctly implemented on site to meet requirements for new product development and lifecycle management for drugs and medical devices including ICH, 21 CFR, EMA, ISO 13485 and 14971, MDSAP, MDR.
• Ensure Quality System processes are correctly implemented on site to meet requirements for pharmaceutical product testing and release.
• Proven track record of documentation review for accuracy and compliance to procedures essentially in analytical methods development/validation/transfer, stability studies, Design & Development.
• Demonstrate compliance of development processes and change management during audits and inspections, participate as auditor in internal audits + follow-up activities.
• Provide Guidance on maintenance of product Design History Files and Risk Management Files according to relevant Quality System and other regulatory requirements for therapeutics and medical devices.
• Interface with Research & Development, Regulatory Affairs, Manufacturing and other disciplines to represent QA in project teams, with the objective to assure that the project quality objectives are met.
• Act as QA Approver for Laboratory Out of Specification (OOS), for Quality System Change Controls (CC) and in Non-conformance or /Corrective Action Preventive Action (CAPA).

Qualifications

Technical skills:

• Must have strong communication oral/written skills, ability to negotiate; and willing to participate in team activities.
• Individual must be well organized, pay meticulous attention to details, and be customer focused with strong interpersonal skills.
• Ability to work independently and with minimal supervision.
• Compliance knowledge in the areas of pharmaceutical product development, laboratory control, change control, CAPA.
• R&D minded.

Language skills:

• English is a must,

Computer skill:

• Microsoft Office application.
• Knowledge required: Word, Excel, Outlook, Sharepoint.
• Usage of Trackwise is an asset.

Education and Experience

Education:

• University degree in Engineering or in Sciences (Pharmacy, Chemistry, Biochemistry or Chemical Engineering)

Experience:

• 7 - 10 years in R&D of Pharmaceutical/Medical Devices industry per EU and/ or FDA requirements (GLP/GMP/ISO 13485 regulation).
• Experience in Durg development, Therapeutic Goods  and GLP environment for conducting the nonclinical R&D studies
• Experience in Quality Initiatives (processes, systems, improvements) is a must.
• Field of expertise: Analytical method development/validation, laboratory activities or stability studies is an asset

Reasonable Accommodations
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