Network Strategy Support Specialist (Serialization)

Company: ProStaff Solutions
Location: New Brunswick
Posted on: June 21, 2022

Job Description:

Direct Hire
Responsibilities--- Will be subject matter expert at sites(s) for serialization and track and trace activities relating to US DSCSA compliance.--- Support cross-functional site team with regards to track and trace systems implementation, setup, validation, monitoring, and maintenance.--- Lead serialization systems issue resolution activities with cross-functional team.--- Ensure manufacturing site(s) connectivity to L4 system is always maintained for receipt of upload of data.--- Ensure commissioned SN data flow from manufacturing sites to downstream partners, if applicable.--- To participate in serialization related workshops, trainings and meetings.--- Collaborating with end-users to identify and define use-cases.--- Ensure serialization relevant training is conducted for all end-users as per requirements.--- Participate and support change control management process with other internal stakeholders.--- Review technical and validation documents shared by vendor relevant to site serialization systems.--- Facilitate vendor assessments, risk assessments, technical evaluations, and SOP generation as per business processes.--- Performs other duties relating to packaging operations on need basis as per situational requirements.--- Undertake serialized product alerts analysis for US and EU market products.--- Participate in investigation of complaints of serialized products with cross-functional team.--- Conduct weekly reviews with site teams and maintain summary dashboards.--- Should have hands on experience of packing operations, Technical knowledge of packing line equipment's.--- Having thorough knowledge of CGMP practices. .--- To generate ideas of process simplification and implement such ideas to increase productivity and reduce rejects and downtime.--- Develop and maintain professional relationship with all external vendors and contractors and improve efficiency process through incorporation of new technology.--- Having experience of handling deviations through proper compliance process, investigate packing complaints along with resolutions and implement Corrective and preventive Action.--- Harmonization of process followed for packing operations as well as serialization and implement the same at site.

Job Qualifications:--- Bachelor's degree in any science subject.--- Must have good understanding of serialization and track and trace regulations, e.g., US DSCSA, EU FMD, Russia, Brazil, India and GS1 compliance.--- Project management of projects involving large number of internal and external stakeholders.--- Good verbal and written communication skills.--- High proficiency in MS office application, particularly, excel and power point is desired.--- Must be able to work independently, if required--- Experience of working with serialization systems and L4 solutions desired

Keywords: ProStaff Solutions, New Brunswick , Network Strategy Support Specialist (Serialization), Other , New Brunswick, New Jersey