Specialist Ii

**About Convatec**

Purpose of the function/ position and functional area:
**Purpose of the function/ position and functional area**:
The purpose of this position is to assure that the implementation of the Label Change are being done in a timely manner, safe and effective.

**Responsibilities**:
Label Change Coordinator:

- The label Change Coordinator is the contact person in Mexico label changes; when a change starts the label change coordinator will be the leader of the changes having the following responsibilities.
- Start the change CCR process once all the details are given and clarified.
- Properly plan the label changes to meet the required implementation date.
- Coordinate the activities in the label change accordance with the requirements & information given.
- Responsible for the creation/modification of the packaging specifications, assuring that they are always updated accordingly.
- Responsible for the address list that shall always be updated.
- Responsible for assigning CR ID number and evidence of the same in the corresponding folder / drive for Artwork & Labeling Team DK / MX.
- Participate in Artwork & Labeling Team.
- Participate in approval of artwork and run-in test.
- Be involved in Major Changes activities.
- Train persons being involved.
- Support testing of new items, tests in Code Soft System.
- Control artwork files.
- Continue as step revision of the open changes.
- Assure proper implementation of the change.
- Maintain documentation of the change.
- Bring a continuous communication with the different departments for the proper and timely implementation of the change.

**Interfaces**:

- Label Change Coordinator must communicate with:

- Artwork & Labeling Team DK/MX
- Production MX
- Logistics DK/MX
- Sales & Marketing DK
- QA/QC DK/MX
- Customers

**Projects support**
- In addition, the label changes coordinator is also a support to the local manager
- Create new templates for test

**Product analysing**:

- Work together with quality those criteria that are not defined for the resolution of visual problems.
- Rejections in the projects inspections which cause is not known.
- A Trend in claims.
- In general, it is expected that this position will help in general to improve the production processes at any time.

**General Activities**
- Support the Project manager in the requirements of the Quality Assurance System based on ISO 13485 and FDA CGMP regulations.
- Responsible for the creation of procedures, instructions and forms applicable for the position.
- Maintenance and safe keeping of records applicable for the position in accordance to the good documentation practices.
- To comply with the company quality policy.
- To follow, develop and acting according to Quality Assurance System based on ISO 13485 and FDA CGMP regulations.

**Powers**:

- The label change associate is empowered to propose changes in the label changes system as action of continuous improvement to the Artwork & Labeling Team Manager.
- Generate CAPAS on nonconformities found.
- Propose recommendations to the Project Manager.

**Safety, Health and Environmental Responsibilities**
- Comply with safety, health and environmental policy, procedures established by the EHSMS.
- Maintain applicable documented information related to the EHSMS up to date.
- Participate in committees, trainings, and awareness, to ensure proper competency of their position if applicable.
- Be aware of and support compliance with applicable significant environmental aspects and associated significant environmental impacts.
- Understand EHS risk and legal requirements relating to job responsibilities and appropriate requirements.
- Execute job responsibilities with professional care and in compliance with legal requirements and internal standards without compromising the safety of self and others.
- Be alert to EHS hazards in the workplace, responding to them as appropriate and communicating them to responsible management as soon as they are identified (e.g., spills).
- Help drive continuous performance improvement in EHS areas, recommending potential improvements to responsible management.
- Participate in identifying opportunities for improvement and implementing the necessary actions to achieve the intended results of their activities.

**Success criteria - international**
- Effective implementation of the label changes.
- Detailed revision of the documents (label specifications, address lists, others) that are involved in the proper implementation of label change.
- Effective coordination of the label changes.

**Demands for education, training and competence - international**

**Job profile**
- Min. 2 years work experience in projects (manufacture, improvement, quality, etc)
- Fluent verbal and written English (required).
- Experience in project management, be part of a project, SME.
- Familiar with the use of computer software.
- Building productive relationships with design teams (such as: branding, human factor, marketing) and