We’re currently recruiting for an exciting opportunity with an award winning biopharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
• This role will support the documentation strategy for all disciplines to ensure business, engineering, quality and compliance goals are met for the project, while adhering to GEP/GMPs.
• Administration and support of the relevant electronic document management systems (EDMS)
• Coordination of engineering documentation control activities on the project:
Ø Coordination with system owners of Standard Document Indexes (SDI) for all turnover packages, and external vendors including coordination of Vendor and Trade turnover packages (VTOP, TTOP) to ensure alignment of the process.
Ø Coordinates review and approval workflows for engineering and project documentation
Ø Responsible for coordination of drawing repositories, engineering documentation, vendor documentation workflows, including coordination of the transmittal process.
Ø Tracks documents through these processes and gives support to relevant users accordingly.
Ø Maintain Document Matrices/Registers for the project as required.
Ø Develops and applies project procedures in line with cGMPs and GEPs.
Ø Manages, stores, prepares, catalogues documents for archival and retrieval when required.
Ø Coordinate document turnover schedule and registers with PM/Sisk.
Ø Maintain hardcopy documents and reference drawing stick sets for the project team.
Education & Experience
• Degree in Science or Engineering related discipline desirable, but not essential.
• Experience working on large capital projects essential.
• Experience in POET, FusionLive, Documentum, EFMS, BlueCielo desirable.