Documentation Specialist

  • Contract
  • Dublin

Website TPM04754

Summary:
Our client, a biopharmaceutical company located in Dublin, is looking for a Documentation Specialist. The successful candidate will be supporting the downstream operations team and be responsible for the timely, accurate and efficient management of documents including access and revision control.

Responsibilities:

  • Manage “Live” Documentation updates from the Operations floor.
  • Turnaround and issue documentation as per Operations Schedule.
  • Manage and implement on the floor documentation control system.
  • Drive the Documentation Life Cycle System to ensure documents are approved in as per Scheduling requirements.
  • Work with various Subject Matter Experts to ensure technical documentation updates are approved.
  • Creation and revision of Standard operating Procedures (SOPs) and Work Instructions (WI’s) as required.
  • Work closely with QA, Supply chain and Operations core functions.
  • Ensure compliance with all regulatory GMP, Safety and Environmental requirements.

Qualifications & Experience:

  • Minimum level 6 in a relevant Qualification.
  • Experience working in a Pharmaceutical GMP regulated industry desirable.
  • Experience working with GMP Documentation Management Systems.
  • Proficient in Microsoft Office Tools (Word/Excel/PowerPoint).

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