Documentation Labeling Specialist

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

We are seeking a Documentation Labelling Specialist to join us in Castlebar for a 6 month contract. As a Documentation Labelling Specialist you will work closely with our Training and Compliance, Validation, Engineering and Manufacturing teams.

What you will be doing

• Collaborate with departments and process documentation on Vantive Documentation system Team centre (TCU)
• Perform issuance of Documentation post approval on Vantive Documentation system TCU
• Perform Obsoletion of documentation as required
• Coordinate periodic review of documents
• Complete role in compliance with current Global issued and effective documents and coordinate global document implementation on site.
• Issue/ coordinate documentation-related training to site
• Coordinate archiving of documents.
• Identify and Implement improvements to documentation and associated processes
• Project support activities and provide guidance to others on documentation activities/ processes
• Participate in Internal/ External Audits as required
• Perform other Documentation Activities as required by the team
• Compliance to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Compliance to Environmental Health & Safety (EHS) requirements

What you will have

• Ideally experience in a Quality environment
• Ideally experience working in a highly regulated industry
• Excellent attention to detail
• The ability for critical thinking and problem solving
• The ability to communicate and work with all manner of team members, in a conscientious and inclusive way
• Good organisational, coordination, and communication skills
• Good working knowledge of Microsoft Applications, Word/ Excel, PowerPoint, Team centre (TCU), Trackwise Change control
• Highly motivated self-starter and team worker
• Effectively handle high-volume and prioritization of tasks

Some of what Vantive can offer to you

• 25 days holiday plus Public Holidays and perfect attendance days ( up to 4 per year)
• Private Health Insurance
• Life Insurance
• Pension
• Subsidised Canteen
• Onsite parking

Reasonable Accommodation

Vantive 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. Form Link

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