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Serialisation Lead

  1. North West
  1. Contract
Competitive
24849
  1. Life Sciences
Date Posted21 May 2020
Serialisation Lead- Global Pharmaceutical Client – 6 Month Contract in North West, England

Our client that specialises in the treatment and prevention of serious human medical conditions is currently seeking the expertise of a Serialisation Lead to support the implementation of a new serialisation programme on their site based in the North West of England.

Essential Duties and Responsibilities for this role include, but are not limited to, the following:
  • Interact with the Corporate serialisation team to ensure network wide alignment on serialisation technologies and processes.
  • Ensure the site is aligned on serialisation activities.
  • Review and update specifications to define the business and technical requirements for serialisation
  • Ensure Project and Validation lifecycle documentation are in place to support the project in a compliant manner.
  • Lead end to end FAT/SAT, commissioning testing
  • Support qualification activities.
  • Ensure Coordination of integration between global SAP and packaging line.
  • Ensure Software Management release process is in place
  • Ensure Coordination of integration between global SAP and serialization systems across the IT stack
  • Support vendor contract Control (Marchesini and Optel)
  • Prepare SOPs for operational use and management
  • Provide support to the Packaging Lead to ensure a co-ordinated approach between systems.
  • Provide support for the technical management of the appointed OEM’s
  • Support the integration of the packaging line with the Optel LineMaster and Pharmaproof equipment.
  • Support the development of lifecycle documentation, namely specification, criticality assessments, RTMs, FAT and SAT protocols.
  • Support training activities for end users.
Requirements:


  • Previous working experience on a Serialisation project within the pharmaceutical industry
  • Extensive risk management experience including the ability to identify, report and resolve risks within the project.
  • Strong experience in lifecycle documentation development.
  • Experience of supporting the project plan and ability to report progress on the plan to affected stakeholders.

If you are interested in this role, please apply now for more information!



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