Post by Christelle et Amandine on Sept 14, 2015 14:12:28 GMT
Global Product Surveillance – Regulatory Affairs - 15000A7T
Job Posting: 14/09/2015
Starting date: 01/01/2015
Description of the company
Baxter International Inc. provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; bio surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s 50,000 employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Purpose of the Job:
This position is responsible for complaint handling activities, specifically the processing of complaints and vigilance.
Essential Duties and Responsibilities:
• Process complaints, per procedure
o Collect necessary complaint information
o Determine reportability of a complaint and submit associated MedWatch reports within 30 days per regulations, following review by higher level specialist
o Evaluate complaint for need to investigate
o Document investigation results
o Respond to customer complaints (written or verbal), following review by higher level specialist
o Timely closure of complaints
o Manage workflow; identify and escalate issues
• Participate in process improvement activities and projects
• Participate in CAPA related activities
Qualifications:
• Knowledge of FDA Quality System and Medical Device Reporting regulations (21 CFR 803, 820 and 211).
• Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures.
• Solid written/verbal communication and organizational skills.
• Knowledge and application of computer systems for word processing and complaint management.
• Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
• Advanced critical thinking skills, including the ability to spot trends and emerging issues.
Education and/or Experience:
• A minimum of an Associate’s Degree required in pharmacy, medical technology, engineering or scientific background (MLT, LPN, RN).
• Bachelor degree and /or clinical certification (MT, RN) preferred.
• 1 year work experience in a cGMP related industry or in a clinical setting.
We are looking for someone who will be active, motivated in order to be efficient quickly. Moreover, this position needs to be sociable and to work in team most times.
Characteristics of the job
Baxter has a range and variety of jobs on offer in a positive and dynamic environment that allows you to maintain a healthy work-life balance. We provide a variety of development opportunities as part of our comprehensive Talent Management Program. Your contribution to the company’s success will be rewarded with a competitive salary package. We offer comprehensive benefits to suit the lifestyles of all our employees, from a retirement plan that is far above market average, a save-as-you-earn program, to educational scholarships for children, and health management initiatives for staff and their dependents.
Baxter is a truly diverse and global company. We are an equal opportunity employer and welcome applications from all candidates.
Job Classification: non experienced
Job: QUALITY
Organization: US/Canada Operations
Primary Location: Inited States-Coloradp-Englewood
Schedule: Full-time
Travel: No
If you are interested, contact us at recruitement@baxter.com with the indication of job reference.
Quality Assurance auditor manufacturing (m/f) - ref15001A8P
Job Posting: 14/09/2015
Starting date: 01/01/2016
Description of the company
Baxter International Inc. provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; bio surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s 50,000 employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Purpose of the Job:
Baxter is looking for a Quality Assurance Auditor (m/f) to be based in any European Baxter affiliate.
Essential Duties and Responsibilities:
• Independently conducts assigned audits of global Suppliers and TPMs to assess compliance to all applicable External Standards and Regulations as well as Baxter Quality System requirements; may participate in audits of manufacturing and commercial affiliate sites
• Ensures compliance to Division and Corporate policies and procedures by promptly reporting non-compliance issues
• Provides compliant solutions to problems of moderate scope and complexity
• Leads projects with limited scope; acts as a core team member in broad / complex projects; contributes to defining and timely achievement of project goals
• Maintains and demonstrates understanding of global standards, regulations and regulatory bodies
Qualifications:
• Apprenticeship or Bachelor's degree in Life Science, Engineering or closely related discipline is required; minimum of 1 years of related experience in the medical device / pharmaceutical industry
• Knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820; ISO 13485; IVD; PAL.
• Trained in auditing techniques; Certified Auditor qualification or equivalent is preferred.
• Excellent written and verbal communication skills
Skills/Education:
• A minimum of an Associate’s Degree required in pharmacy, medical technology, engineering or scientific background (MLT, LPN, RN).
• Bachelor degree and /or clinical certification (MT, RN) preferred.
• 1 year work experience in a cGMP related industry or in a clinical setting.
We are looking for someone who will be active, motivated in order to be efficient quickly. Moreover, this position needs to be sociable and to work in team most times.
Characteristics of the job
Baxter has a range and variety of jobs on offer in a positive and dynamic environment that allows you to maintain a healthy work-life balance. We provide a variety of development opportunities as part of our comprehensive Talent Management Program. Your contribution to the company’s success will be rewarded with a competitive salary package. We offer comprehensive benefits to suit the lifestyles of all our employees, from a retirement plan that is far above market average, a save-as-you-earn program, to educational scholarships for children, and health management initiatives for staff and their dependents.
Baxter is a truly diverse and global company. We are an equal opportunity employer and welcome applications from all candidates.
Job Classification: non experienced
Job: QUALITY ASSURANCE
Organization: Baxter-Diagnostics
Primary Location: Germany-Hesse-Wiesbaden
Other Locations: Spain-Community of Madrid, Italy-Lazio-Rome, Netherlands
Schedule: Full-time
Travel: Yes, 50 % of the Time
If you are interested, contact us at recruitement@baxter.com with the indication of job reference.
