Labelling Rep
Type
Full time
Location
Job reference
Req-39642
Posted for
1 day ago
Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Labelling Representative position is a unique career opportunity that could be your next step towards an exciting future.
The Labelling Rep is accountable for ensuring that all work associated with updates or changes to global labelling standards/procedures, training plans and process improvements, routing and approval of assigned labelling deliverables through ECR and PDM processes is carried out in compliance with relevant standards and regulations
Key Responsibilities:
Execute more complex label change packages (e.g., redlines, ECR generation and processing, compiling documentation, data entry) by ensuring documents conform to established grammatical and formatting conventions, templates and within a specific business unit with minimal supervision. Summarize and capture change intent accurately within quality system (e.g., ECR) in adherence to GDP (Good Documentation Practices). Actively follow up on change requests (e.g., SARS, ECRs) and manage approvers to ensure timely closure
Update routine procedures and recommend process improvement opportunities
Evaluate routine risks and provide recommendations to resolve issues.
Other incidental duties, including working with different suppliers and vendors for accurate execution of labelling component
Education and Experience:
Associate's Degree (or equivalent) plus 2 years' of related work experience required or Leaving Cert (or equivalent) plus 4 years' of related work experience required
Additional Skills:
Good computer skills including usage of MS Office Suite
Good written and verbal communication skills and interpersonal relationship skills
Good time management and organizational skills
Able to read, comprehend, write, and speak English
Good knowledge and understanding of policies, procedures, and requirements as it relates to task execution within labelling operations
Good knowledge of labelling systems and applications (e.g., ECR and PDM processes)
Strict attention to detail
Must be able to work in a team environment, including inter-departmental teams
Provide feedback in a professional, direct, and tactful manner
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Important Notices for Candidates
COVID Vaccination Requirement Notice
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
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