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Labeling Operations Project Leader

Req #: 1700080Q_en
Location: Lessines, BE
Job Category: Quality
Date Posted: 9/26/2017 7:31:10 AM
Baxter International

Description

Our employees around the world are connected by an enduring commitment to save and sustain lives. This higher purpose binds us as a company in doing work that matters.
 
The Job
 
Overview
  • You will support EMEA Change Control Office in managing cross-functional change controls related to labeling and relabeling of Medical Products in Region EMEA,
  • You will act as Project Coordinator for label changes impacting Region EMEA MP manufacturing sites and act as a central contact between all the stakeholders impacted by a labeling change request,
  • You will also act as change control owner for label change impacting MP manufacturing sites in Region EMEA (for the plants in scope of labeling change control centralization)
  • You will analyze labeling related quality data for trends and potential areas of improvement
  • You will ensure that processes and procedures related to labeling activities, including change controls, are compliant to local  Regulations, to the Corporate Quality Manual, ISO 9001/13485 requirements and to Regional and Corporate procedures
  • You will give support in maintaining and implementing labeling strategy in accordance to the business,  Quality and Regulatory requirements,
  • You will ensure appropriate contacts with Country Regulatory Affairs (RA), Divisional and EMEA RA,  Supply Chain, QA manufacturing, Country Quality Assurance (CQA), QA EMEA organization and Businesses are maintained
 
As part of your role, you will:

  • Be responsible for managing multiple labeling change control projects encompassing a varying degree of scope and complexity.
    • Organize and facilitate label change control project updates and approval meetings, as appropriate
    • Perform accurate product and project data entries in a change control management system.
    • Assist in tracking and communication of project risks
    • Coordinate project documentation
    • Create and maintain project schedules
    • Assist in tracking team deliverables for project completion
    • Support project communication by interacting Project Core Team and extended teams to ensure effective communications and manage expectations
    • Work within the guidelines of the organization's project office model, standard performance metrics, and regulatory guidelines to support, plan, monitor, control, and implement projects
  • Support labeling team project initiatives
  • Support relabeling change controls
  • Provide with change control guidance and oversight to the Baxter EMEA MP plants not part of the change control centralization
  • Be responsible to understand and comply with change control and labeling design and development procedures
  • Collect and consolidate information required to initiate change controls related to label changes
  • Liaise with the Subject Matter Experts from the different functions (Regulatory, Labeling Center, Manufacturing, R&D, Quality…) and coordinate the assessments supporting label change controls
  • Organize the change control activities in a compliant change plan
  • Lead and closely track the change control execution and implementation activities related to Labeling Change Requests
  • Collect, analyze, evaluate data to identify trends or anomalies and escalate as appropriate
  • Support the implementation of the QMS in labeling change control team to ensure that all relevant SOP's are in place and comply with Baxter policies, EMEA, Local and Corporate requirements,
  • Support audit and inspection program as well as Baxter MP manufacturing plants in case of internal and external inspections (for labeling process)
  • When required, provide support and expertise for CAPA related to labeling. Act as CAPA owner, CAPA investigator or QA Approver
  • Support training program of EMEA labeling team, ensure training records are maintained. Deliver training upon request or when required to other personnel (e.g.: RA, Supply Chain, Quality Mfg)

Qualifications

Who you are
 
You have
  • A master degree in life-science or engineering
  • 1 to 3 years industry experience in Pharmaceutical or Medical device related industry.
  • An excellent level of English (Spoken, Read, Written)
  • Knowledge of ISO9001 or ISO13485 requirements
  • Knowledge of Word, Excel, Powerpoint and Microsoft Office
  • Good project management skills
  • Quality System processes knowledge and experience (particular experience in change control process is a plus)
  • A pragmatic approach, hands-on attitude
  • Strong analytical/problem solving skills
  • Excellent team-work and collaboration skills
  • Strong communication skills: needs to cascade information both ways and ensure consistent, concise, clear messages to all, influence others skills
  • Eagerness to learn, strong motivation
  • Positive approach, optimism
You are
  • Results oriented with a process and quality driven approach
  • Self-driven with the ability to work independently as needed
  • Critical thinking and you have the ability to challenge the status quo
 
What we offer
 
It is a challenging opportunity for you and also a chance to work in a diverse team with a great mix of people.  Joining Baxter means joining a team that you can truly learn from!
We encourage our employees to develop their skills to meet the demands of an ever-changing work environment, providing them with opportunities - such as training, mentorship programs and other development opportunities - to achieve personal and professional goals that will make them valued contributors throughout their careers.  If you have an interest in this great opportunity and think you can make a difference then this could well be the role for you.  We are also committed to enhancing opportunities for flexible working arrangements, compatibly with the position and responsibilities.
If you want to learn more about career opportunities, go to http://www.baxter.com/careers.page
 
Who we are
 
Baxter touches millions of lives every day.  Our products and services are essential building blocks of healthcare.  You’ll find Baxter’s products and therapies on nearly every floor, in almost every hospital worldwide.  You’ll find us in clinics and in the home.  Patients and providers rely on Baxter for lifesaving renal and medical products.
Our mission to save and sustain live inspires our work and our commitment to expanding access to care, providing cost-effective healthcare solutions, delivering quality products and advancing innovations for the world.
Our 50.000 employees serve patients and clinicians in more than 100 countries and are dedicated to ensuring Baxter is there when patients need care.
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