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Documentation Specialist

  1. Cork
  1. Contract
Competitive
  1. CAPEX Projects
16-08-2023
31453

This vacancy has now expired

Documentation Specialist – Cork – Pharmaceuticals

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.

Essential Duties and Responsibilities for this role include, but are not limited to, the following:
  • Creating, editing, and formatting of SOPs, Work Instructions, and other documents on the clients EDMS 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 in Cork.
Requirements:
  • 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).
If you are interested, please apply now for more information!!

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

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