Operations Documentation Specialist

  • Contract
  • Dublin

Website Ref: TPM04168

Summary:
An Operations Documentation Specialist is required for a biopharmaceutical company in North Dublin.

Responsibilities:

  • Responsibility for the timely, accurate and efficient management of documents including access and revision control.
  • Manage and implement on the floor documentation control system.
  • Creation and revision of Standard Operation Procedures (SOP’s), Work Instructions (WI’s) are required.
  • Drive the Documentation life cycle system to ensure documents are approved in timely manner as per scheduling requirements.
  • Work with SME’s and various internal and external stakeholders to ensure technical documentation updates are created and approved.
  • Collaborate with QA, Supply chain and Operations core functions.
  • Ensure Compliance with all regulatory GMP, Safety and Environmental Requirements.
  • Report status of documents, identify areas of opportunities and action plans required.
  • Coordination of Quality Notifications, CAPA’s and overall Deviation management.
  • Manage ‘’Live’’ Documentation updates and report progress on documents
  • Ensure effective planning, common understanding and targets for specific documentation
  • Maintains a thorough knowledge of documentation needs.
  • Provide updates on a regular basis to functional directors, associate directors managers on deviation, documentation and CAPA’s.
  • Identify Risks, Gaps and Opportunities related to documentation – work with Area Owners and Subject Matter Experts to ensure documentation updates are approved.
  • Collaborate with all the site functional areas and other support teams.

Qualifications & Experience:

  • A minimum of level 6 qualification in a Science, Engineering, or Project Management discipline.
  • Experience in the Pharmaceutical GMP regulated industry desirable.
  • Excellent verbal and written communication skills.
  • Ability to work independently and as part of a team in a cross functional collaborative environment.
  • Experience working with GMP Documentation Management Systems.
  • Should be proficient with Microsoft Office tools, (MS WORD/PowerPoint/ Microsoft).
  • Experience with SAP/Trackwise/Veeva Quality docs advantageous.
  • High level of attention to detail and strong planning ability.
  • Experience with technical writing.

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