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Production Lead - Serialisation

Job Title: Production Lead - Serialisation
Contract Type: Contract
Location: Mayo
REF: 98800
Job Published: 23 days ago

Job Description

Contact: Caroline Kingston
Telephone: 086 8395531

Production Lead
Our client, a pharma company in Mayo are currently looking to recruit a Production Lead for their site.

Job Summary:
Support Serialisation (Track & Trace) initiative by providing production support in developing SOPs and Batch Records, manage change control implementation, support ECR management, develop and administer training materials, liaise with product release and customer support and other production serialisation support requirements. The production coordinator will be responsible for supporting the day to day production and new line introduction of the Track & Trace solution throughout the Mayo site.
Responsibilities 90%
  • 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
Administration / Meetings 10%
  • Attend twice-weekly Serialisation APEX meeting
  • Attend monthly Department meetings
  • Attend external meetings as required
  • Attend monthly 1:1 meeting with supervisor

Key Requirements
  • 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.

For further information on this Training Specialist role in Galway please contact Caroline Kingston on 086 8395531 /
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