12 month contract for an experienced Technical writer
This position is a 12 month contract role on site with one of Ireland's leading healthcare companies. This is to assist in a multi-million euro project and first of its kind with this company with their Logistics and warehouse function.
Duties of the role:
- Track and drive the completion of the documentation package for the startup of the Logistics dept.
- Lead the documentation generation and management of the Warehouse/Dispensary procedures & processes. Leading the related execution of the start up plan for the Warehouse/Dispensary department for this
- Be a "go-to" person in the Warehouse and Dispensary document control, providing key guidance for documentation related issues
- Help in the start-up of the Warehouse & Dispensary Operation, helping the team to support with all documentation related issues as it related to C&Q activities, developing processes/SOP and giving input in the development of COMET (SAP), LIMS and MES.
- As needed by the business, support other related GMP task as needed
- Create and maintain templates for all required forms & templates within the department
- Facilitate document reviews with cross functions groups, Engineering, MS&T, QC, QA, etc
- Implementation corrective and preventative actions which are related to Dispensary, Warehouse & Logistics documentation.
- Contribution towards Warehouse & Dispensary departments non-conformance/deviation write ups, working with relevant staff members to reach a true root cause and ensure improvements to the processes
- Contribute toward, promote & facilitate Continuous Improvements and Process improvements within the Warehouse/Dispensary Operations area. Using best practice lean tools and following Merck Production Systems (MPS) philosophies.
- Ability to use electronic documentation systems for review/approval of SOP's, write up of Deviation/Non-Conformances, etc
- Experience in key Microsoft packages, Word, Excel, Powerpoint, etc in order to communicate messages to shop floor associates, peers and department leaders.
- Knowledgeable on use of equipment used in a RM Sampling/Dispensary Operation, i.e. Downflow booths, scales, Fumehoods, drum movers, etc would be a distinct advantage
- Preference for candidate to have a good knowledge of the overall Drug Substance manufacturing process (Upstream & Downstream processes)
- Ability to understand technical documentation relevant to tech transfer (process flow diagrams, tech transfer documentation, and master batch records)
- Review manufacturer's and trade catalogs, drawings, and other data relative to operation, maintenance, and service of equipment.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.