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Details

Documentation Specialist


Reference:RK20963 Location: Cork
Qualification:DegreeExperience:2-3 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Documentation Specialist

Documentation Specialist
RK20963
Contract – 9 months
Cork



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.




Duties:

  • Creating, editing, and formatting of SOPs, Work Instructions, and other documents 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.
  • 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 Vaccines IPT
  • Ensure compliance with site EHS policy, cGMP and other business regulations and support Technical IPT input to risk assessments, audits, regulatory inspections, and incident investigations


Experience and Education
  • 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.



If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.