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.
- Adhere to and assist in the establishment of and maintenance of up-to-date area SOPs in accordance with Corporate Standards and Regulatory Guidelines.
- 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.
- Adhere to appropriate levels of cGMP.
- Adhere to local safety regulations – e.g. Manual Handling.
- 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.
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.