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Documentation Specialist

  1. Cork
  1. Contract
Competitive
  1. Life Sciences
26-05-2023
31453
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Documentation Specialist – Life Science- Contract – Cork

One of our global Pharmaceutical clients is looking for a Documentation Specialist to join their team close to the picturesque and historical city of Cork. The site is renowned for manufacturing excellence and plays a vital role in the company's large-scale biotech operations worldwide.

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.

Documentation Specialist Responsibilities:
  • Creating, editing, and formatting of SOPs, Work Instructions, and other documents.
  • 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.
About you:
  • 3-5 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).
 

Are you a good fit for a Documentation Specialist? Get in touch with us today.



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

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