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Documentation Specialist

  1. Cork
Cork
  1. Contract
Competitive
  1. CAPEX Projects
35694
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Documentation Specialist - 12 Months + Possible Extensions - Cork 

The site has received €130 million in investment over the last five years to continue the growth and expansion of the facility; with new products coming to the site, it is an exciting time to join the team.


Bring energy, knowledge, innovation, and leadership to carry out the following:
  • Creating, editing, and formatting of SOPs, Work Instructions, and other documents on the EDMS (Veeva Vault) from material supplied by the Vaccine IPT SMEs.
  • Liaison with key stakeholders e.g., Quality, Change Control, SMEs etc. to ensure compliance, correctness, content, and delivery.
  • Lead the tracking and maintaining of the project document delivery schedules for the team (using Excel).
  • Engage with Change Control and the wider project team to ensure documents are prepared and updated in time for different stages of C&Q execution and production.
  • Provides to the site knowledge and experience in Quality Documentation Systems.
  • Responsible for use of the Site Documentation System including Issuance, reconciliation, storage, archiving and retrieval of cGMP documentation to support the manufacture & testing of our products.
  • Responsible for maintaining the Site Master file for current effective cGMP documents on site at Brinny.
  • Uses knowledge to improve Quality Documentation Systems, solve problems, provide continuous improvement, and execute tasks.
  • Provides compliance contribution to project teams and leads small projects.

What skills you will need:

In order to excel in this role, you will need to have:
  • 1-5 years’ experience as a documentation specialist or equivalent in a pharmaceutical or a highly regulated environment.
  • Experience in maintaining and updating excel schedules and trackers for small projects.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • Stakeholder management of multi decision makers, colleagues, peers, and cross functional teams.
  • Knowledge and experience of GMP and GDP in a pharmaceutical environment.
  • Desirable: Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g., Manufacturing, Quality, Engineering, Tech Services etc).
  • Desirable: Qualification in a biological science subject.
  • Desirable: Evidence of Continuous Personal Development.

If this role is of interest to you, please apply now! 

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