Sr Quality Assurance Manager
Sr Quality Assurance Manager
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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
The Senior Quality Assurance Manager is responsible for assuring conformity of the manufacturing processes and products to the quality requirements (procedures and regulations) manufactured at Lessines site.
Essential Duties & Responsibilities
Supervising all activities at plant level as related to Operational Quality Complaints and Release.
Assure escalation of any potential FA and gather data to assist FA process.
Support product release by ensuring timely review and investigation of deviations related to the manufacturing process.
Support NCR and CAPA process: root cause identification and continuous improvement.
Ensure timely documentation and closure of NCR CAPA and complaint records.
Ensure timely investigation and response to ICARs.
Review and assess process and documentation change requests.
Participate in internal and external quality system audits conducted by the corporate or regulatory agency representatives.
Collaborate with ICO partners for projects or issue resolution (intracompany).
Support quality systems by driving regulatory compliance and continuous improvement activities in accordance with applicable regulations and business goals and objectives.
Ensure training is completed for area of control.
Perform reporting of KPI as applicable (CAPA review board Management Review)
Support 6s program.
Response Quality on the shopfloor during visits / audits.
Manage support and develop the Operational Quality Complaints and Release teams.
Monitor KPI and take action to meet target for the department
Qualifications
Bachelors degree in a relevant scientific discipline; advanced degree preferred
Minimum of 10 years of experience within the pharmaceutical industry with progressively increasing levels of responsibility
Minimum 5 years of experience in people management
Fluency in French and English is a must
Being recognized as Qualified Person as defined in the Directive 2001/83/EC for Medicinal products and as defined in DIRECTIVE 2001/82/EC for veterinary medicinal products is an added value
Problemsolving and analytical skills
Critical and inquisitive mind
Excellent communication and presentation skills
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
