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.
- 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!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
North West England
Project Engineer - Global Biotech Organisation - Liverpool Our client that specialises in the treatment and prevention of serious human medical conditions is currently seeking the expertise of a
North West England
Project Manager - GlobalBbiotech Organisation - North West Our client that specialises in the treatment and prevention of serious human medical conditions is currently seeking the expertise of a
Send us your CV
Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.