Document Controller

Website TPM04783

Summary:
A Document Controller is required for a biopharmaceutical company in Waterford. The successful candidate will play an integral role supporting a digital paperless project ensuring the creation, storage, issuance, and retrieval of all documentation in a manner which meets cGMP requirements.

Responsibilities:

  • Define, manage, and maintain a documentation control system for QC projects & BAU cGMP documents.
  • Manage, index, and control the QC on-site and off-site documents.
  • Create and maintain QC procedures.
  • Train QC site personnel on the Documentation Management Processes and QC project implementation.
  • Define, manage, and maintain QC project key metrics ensuring site visibility, strong internal customer satisfaction and trending to support continuous improvement activities.
  • Supporting and providing appropriate information to support Product Performance Reviews (PPR).
  • Support and report right first-time documentation findings to support continuous improvement initiatives.
  • Participate in internal audits, support all external audits and any key quality Initiatives.
  • Ensure issuance and storage of QC and Projects documents.

Qualifications & Experience:

  • Leaving Certificate or equivalent and will preferably have secretarial and/or clerical qualification or accreditation.
  • Minimum of 3 years experience in similar role.
  • Very good knowledge of cGMP in a regulated.
  • Strong Planning/Organising skill.
  • Good Presentation skills.
  • Working knowledge of computer systems.
  • Project Management skills and experience a distinct advantage.

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