Documentation Specialist

  • Contract
  • Cork

Website TPM05393

Summary:
A Documentations Specialist is required for a biopharmaceutical company in West Cork. The incumbent will provide documentation support creating, formatting, tracking of SOPs and work instructions in the Electronic Document Management Systems.

Responsibilities:

  • Creating, editing, and formatting of SOPs, Work Instructions, and other documents on the EDMS from material supplied by the team.
  • 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.
  • 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.
  • Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
  • Part-take in cross-functional problem-solving teams for troubleshooting and investigations within the team.
  • Ensure compliance with site EHS policy, cGMP and other business regulations and support Technical input to risk assessments, audits, regulatory inspections, and incident investigations.
  • Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.

Qualifications & Experience:

  • 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).
  • Desirable: Qualification in a biological science subject.
  • Desirable: Evidence of Continuous Personal Development.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.