Documentation Analyst
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Job Type | ContractorFixed Term |
Area | Mayo |
Sector | QualityLaboratory/ScientificOperations & ManufacturingRegulatory |
Start Date | |
Advertiser | Mary King |
Job Ref | 1002649 |
Job Views | 291 |
- Description
- Team Horizon is seeking a Documentation Analyst for our client based in Mayo ona 3-month fixed-term contract. As our new Documentation Analyst, you are responsible for the generation/review of (PMRs) Packaging Master Records, the production of artworks and SAP Bills of Materials.
Joining a well-established team your role will ensure compliance with local QA/Production and Regulatory Affairs requirements regarding safety, housekeeping and GMP's and support and comply with internal environmental, health and safety requirements, procedures, and policies.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
Collaborate with Planning, Purchasing, Production, QA, Regulatory Affairs and EHS to ensure all internal procedures meet industry regulatory standards.
Assist in the creation and review of PMR's received for multiple business units.
Verify artwork copy received for accuracy and consistency.
Create and maintain bill of materials in SAP
Issue and control of completed PMR master forms.
Follow up on queries from Vendors / QA in relation to artwork supplied.
Assist Documentation Manager in dealing with queries and requests from internal and external contacts as required
What you need to apply:
Leaving Cert or equivalent. 3rd level qualification preferred.
Knowledge/Experience of Packaging systems and processes an advantage
Knowledge/Experience of Production or Batch paperwork preferred
Working knowledge of SAP, One Vault, PAMS and Trackwise preferred
Proficiency in Microsoft Platforms, specifically Word & Excel
Excellent teamwork, interpersonal, communication, organization and decision-making skills.