Documentation Specialist

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Job Description

Cpl, in partnership with our client Pfizer, are currently looking for a Documentation specialist with experience in GMP and implementing systems to work in their state of the art biologics facility based in Grange Castle.

Job Role & Responsibilities:

  • To maintain compliance through established programs for the receipt, storage and archiving of GMP Documentation.
  • Technical Lead in assuring efficiencies/space creation within the Quality & Engineering areas – e.g. archival of cGMP Documentation.
  • Control and maintain the filing system for retrieving and archiving of Data Packs/ Engineering Data Book/Reports/Protocols/Commissioning Test Pack.
  • Ensure timely reporting of data reports in accordance with specific timelines e.g. Weekly project updates.
  • Assist in the preparation of area status reports/plans as necessary.

Documentation

  • Adhere to and assist in the establishment of and maintenance of up-to-date area SOPs in accordance with Corporate Standards and Regulatory Guidelines.

Training

  • Ensure all training requirements are up to date and in-line with current training curricula.
  • Assist in the training of other coordinators/ on departmental SOPs when required.

GMP/Safety

  • Adhere to appropriate levels of cGMP.
  • Adhere to local safety regulations – e.g. Manual Handling.

Planning

  • Ensure work is carried out according to plans devised by the Supervisor of the assigned area.
  • Perform and assist in additional duties as may be directed by the Supervisor of the assigned area.

Education/Experience Requirements:

To be successful in this role you will require:

  • Documentation, administration and archival Skills working in a large multinational
  • Previous QC and or Pharmaceutical experience in a GMP facility, particularly in data storage, archiving, and data formatting, is desirable but not essential.
  • Previous experience with the following Quality Systems: Documentation systems.
  • Excellent communication and interpersonal skills.
  • An ability to work independently as well as a member of a team in a dynamic, fast-paced environment.
Apply via LinkedIn

Emilia Nowak

Recruitment Consultant emilia.nowak@flexsource.ie