Labelling Process Specialist _ Temporary
Abbott
Rome, Italy
5 gg fa

JOB DESCRIPTION :

For Abbott's Established Pharma Division we are looking for a

Labelling Process Specialist

for a temporary contract.

Primary Job Function :

  • Assures on-time execution of Packaging and Label Change Requests (LCR) and matching exactly the requirements of the change requestor with regards to content, technical specifications and implementation date.
  • Assures that implementation of label changes has minimal impact on the supply chain and on other Affiliates who may share the packaging and label.
  • Core Job Responsibilities :

  • Facilitate Label Change process between requestor, often the Affiliate, and the source (internal Plants or Third Party Manufacturers);
  • balancing the requestor's requirements with regards to implementation date with impact on supply chain and the control of write-off costs.

  • Evaluate impact of LCR and shared pack requests on other Affiliates and inform impacted Affiliates.
  • Work with the requestor and the source (internal Plants or Third Party Manufacturers) in order to ensure integration of technical requirements into the label change request.
  • Monitor assigned LCRs in the Agile system. Follow-up with involved stakeholders in case of delays and to ensure a prompt resolution
  • Ensure monthly LCR Monitoring and KPIs review for assigned countries / Affiliates in order to ensure a constant alignment on priorities, prompt resolution of issues and identification of process improvements
  • Support the creation and maintenance of technical documentation and procedures for the processes in charge of the labelling department
  • Ensure quality and regulatory compliance of activities and of the LCR process in line with local procedure and applicable Abbott policies
  • Position Accountability / Scope :

  • The position impacts EPD's ability to meet short and long term growth objectives by launching new products on-time.
  • The position impacts EPD's ability to meeting regulatory and compliance requirements supporting introduction of changes to existing packaging and labels on-time.
  • Key stakeholders include Affiliates, Third Party External Designers, TPM Management, Abbott Manufacturing plants, Supplier and Customer Operations, Business Processes, RA, QA.

    Minimum Education :

  • Any technical or scientific degree or equivalent.
  • Minimum Experience / Training Required :

  • Proven qualification / training on GMP / GxP of Pharmaceutical Products
  • Proven communication skills in English - written and verbal.
  • Excellent knowledge of business systems and tools, such as Agile, Darius, SAP, ATOM
  • Proven knowledge and training on Proof Reading systems (such as TVT and Digital Page)
  • Desired skills / experiences include :

  • Proven communication skills in a main EPD business language other than English is a strong advantage.
  • Demonstrated ability to work effectively and collaborate with a diverse group of stakeholders.
  • Demonstrated accuracy, great attention to detail and understanding of consequences of quality and regulatory non-compliances
  • Issue identification and strong problem analysis and solution development skills.
  • Rome
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