Packaging Serialisation Specialist

The Packaging Serialisation Specialist is required to support the project management of ongoing Contract Manufacturing Operations(CMO)serialisation implementations for a six month contract in Dublin.

The packaging serialisation engineer will provide standard serialisation business cases, which will impact processes at external manufacturing sites. He/she will also define quality concerns where business cases that have been developed could be impacted by serialisation and provide training materials to support change management.

Role and Responsibilities:
. Develop Use Cases, Data Exchange Flow and IT Integration Diagrams for CMO's for cutover to External Manufacturing SRMs (Supplier Relationship Managers) and Quality Personnel
. Provide assistance, guidance and technical support to CMO's and travel to CMO sites in order to support implementation activities as deemed necessary by CMO Serialisation Lead
. Collaborate with CMO Serialisation Lead, SRM and Quality Representatives to ensure proper status communication, risk escalation, and update on progress during execution
. Attend and or Conduct regular meeting with CMO teams to provide project updates to CMO Serialisation Lead,regarding progress toward milestones at each CMO implementation
. Work with the External manufacturing Group, develop or identify internal SOPs impacted by serialisation; revise and develop new documents as necessary. Provide standardised training materials for processes changes for purposes of commercial cutover to serialised product.
. Identify risks and issues across all global serialisation activities at CMOs and recommend action items to mitigate risks and resolve issues
. Support continuous improvement for the processes developed for serialisation

Requirements:
. The incumbent will have 5+ years of relevant experience in the pharmaceutical, biopharmaceutical or related industry and a Bachelor's degree in engineering, chemistry, pharmacy or related sciences with experience in packaging serialisation projects.
. Demonstrated financial and project management skills and success in negotiating complex supply and toll manufacturing agreements with external suppliers is required.
. Operations experience in pharmaceutical manufacturing to cGMP standards including extensive knowledge of regulatory guidelines and validation practices and an ability to effectively transfer complex knowledge regarding science and engineering procedure is essential for the role.

If this is you please apply today