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.