Supervisor Release QA - QP Delegate
Supervisor Release QA - QP Delegate
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Job Description
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. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.
Baxters 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 liveswhere your purpose accelerates our mission.
THE ROLE
- Lead supervise coach and coordinate a team of employees to achieve the objectives of the department(s) for which he/she is responsible. This is achieved by delivering quality products at the best possible cost in a safe and serene environment.
- He/she is responsible at his/her level for monitoring and implementing the companys policy on employee wellbeing and safety.
- Responsible for the management and control of finished product release activities (sterile and medical devices).
- Lead finish product release process improvements both locally as globally driven initiatives.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Responsible for the management and control of finished product release activities (sterile and medical devices).
- Responsible for the coordination and planning of batch file review activities of the complete Quality Assurance Release team.
- Monitor and improve the release performance of the Quality Assurance team. Responsible for KPI (Key Performance Indicators) of both the release process (sterile and medical devices) and release team to be submitted to the Region/Global.
- Facilitate interactions of and ensure appropriate linkage with different stakeholders : Manufacturing Supply Chain Contract Manufacturing Organizations/3rd party suppliers Product development and Quality Assurance team.
- Assure establishing all regulatory aspects (documentation and procedure updates quality agreements...
- Support external and internal audits with release activities in scope as auditee and auditor
- Participate in quality training development and deliver quality training like GMP.
- Participate in the Enterprise Management Systems and 6S implementation
- Lead finish product release process improvements. Implement both locally as globally driven initiatives for improvements.
QUALIFICATIONS
- Degree in Science or Engineering; advanced degree preferred
- Proven experience in a similar or equivalent role and in people management.
- Commitment to quality. Knowledge of GMP (EudraLex Volume 4 and of directives and regulations applicable to medical devices.
- Qualified Person (QP) delegate experience is a plus with associated training qualifications and experience in GMP and QP certification.
- Excellent knowledge of quality systems and compliance.
- Experience in project management.
- Fluency in French and basic English is a must
- Problemsolving and analytical skills and excellent communication and presentation skills
- Critical and inquisitive mind
- Resistant to stress & demonstration of flexibility in times of change
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.
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.
Required Experience:
Manager
Employment Type
Full-Time
