Serialization Production Coordinator
This position will be responsible for:
- Manage QMS CC for new TNT equipment installation, software updates and recipe updates in conjunction with project team.
- Manage SOP updates for new TNT equipment/procedures, develop work instructions in conjunction with TNT project team
- Coordinate training for new and existing operators, setup’s and maintenance staff on TNT and packaging related equipment.
- Liaise with TNT project team to schedule downtime with planning department for equipment installs, recipe updates, all revalidation activity.
- Manage inventory of RD products on SAP for equipment FAT validations and systems updates, liaise with purchasing department for ordering components from external vendors and production planning department for internal components such as water filled bottles vials etc. in advance of line trials
- Liaise with copy cycle to develop new or modify existing RD ECRs for each new TNT installation.
- Review and approve all URS, FMEA and validation documents associated with project.
- Aid system owner with data integrity and audit trail review of all packaging and TNT equipment.
- Take ownership for SAP and EPCIS Interface administration, liaise with copy cycle for setup and review of Master data TNT fields in SAP
- Work with QA and customer services to transition the batch data from the Antares system out to SAP and onto external MOH or CFDA entities
Education and Experience/Knowledge:
- Education: Third level degree/diploma/cert preferred but not required.
- Experience: 3 to 5 years working in a regulated environment. Working in a packaging/production role preferred but not required
- Experience: Computer skills, working with Microsoft Office (Word, Excel, Powerpoint etc). Some SAP knowledge preferred
Essential Knowledge, Skills & Abilities:
- Experience of working on a team, including strong organizational and time management skills.
- Exposure to Trace and Trace system preferred.
- Experience/Exposure with SAP.
- Experience in a GxP regulated environment is preferred.
- Experience with manufacturing systems is preferred.
- Proficient in Windows 7 and Microsoft Office.
- Flexibility to respond to serialization production issues outside normal business hours.
- Ability to learn new and different technologies.