QA Associate

As a Quality Associate II, provide quality support for the successful completion of new and improved product design and implementation projects within the boundaries of quality, time, and budget. Implement and maintain the Baxter R&D Europe Quality System to ensure compliance with the requirements of authorities and internal customers for drugs and medical devices. Specifically, ensure compliance with EU MDR regulation.

Responsibilities:

1. 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, EU MDR.
2. Ensure Quality System processes are correctly implemented on site to meet requirements for pharmaceutical product testing and release.
3. Review documentation for accuracy and compliance to procedures and release or reject as appropriate (essentially Design & Development documents, stability studies, analytical methods development/validation/transfer).
4. Demonstrate compliance of development processes and change management during internal and external audits and inspections. Participate as auditor in internal audits and follow-up activities.
5. 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.
6. Interface with Research & Development, Regulatory Affairs, Manufacturing, and other stakeholders to represent quality function in project teams, with the objective to assure that the project quality objectives are met.
7. Act as quality approver for design and quality system change controls.
8. Participate and approve NCR/CAPA records, supporting the investigation and the appropriate resolution.

As a member of R&D Europe:

Comply with Baxter Quality and Environmental Health and Safety policy.

Technical Skills:

1. Must have experience in developing and sustaining pharmaceutical and medical devices products.
2. Must demonstrate leadership skills to handle change controls, NCR/CAPAs, risk management activities, and problem-solving projects.
3. Must have strong communication oral/written skills, ability to negotiate; and willing to participate in team activities.
4. Individual must be extremely well organized, pay meticulous attention to details, and be customer-focused with strong interpersonal skills.
5. Ability to work with minimal supervision.
6. R&D minded.

Language Skills:

1. Fluent English
2. Good French/Dutch would be a plus

Computer Skills:

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

Application Information:

Please include your first and last name.

Email: @

Phone: Please include your country code.

CV / Resume: Yes, I am currently eligible to work (work permit/visa/citizenship) in the country to which I am applying. No, I am not currently eligible to work (work permit/visa/citizenship) in the country to which I am applying.