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Documentation Specialist - Operations - Biopharma

  1. Dublin
  1. Contract
Competitive
26559WP
  1. Life Sciences
Date Posted26 Mar 2021
Documentation Specialist - 11 months - Biopharmaceutical manufacturing operations

New build Biologics facility have a contract requirement for a Documentation Specialist. Working within operations you will be responsible for the efficient management of documents including access and revision control.
Duties will include:

  • Manage Documentation updates from the Operations floor.
  • Turnaround and issue documentation as per Operations Schedule.
  • Manage and implement on the floor documentation control system.
  • Drive the Documentation Life Cycle System to ensure documents are approved in as per Scheduling requirements.
  • Work with various Subject Matter Experts to ensure technical documentation updates are approved.
  • Creation and revision of Standard operating Procedures (SOPs) Work Instructions as required.
  • Work closely with QA, Supply chain and Operations core functions.
  • Ensure compliance with all regulatory GMP, Safety and Environmental requirements.
Experience required:

  • Experience Working in a Pharmaceutical GMP regulated industry.
  • Excellent verbal and written communication skills.
  • Ability to work independently and as part of a team in a cross functional collaborative environment.
  • High level of attention to detail.
  • Experience working with GMP Documentation Management Systems.
  • Proficient in Microsoft Office Tools (Word/Excel/PowerPoint )
Great company to work for! Call me for further information on this role.

The candidate must have the rights to work in the location stated in the job advert.

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