The Network Strategy Specialist with be a SME at NA Sun Global Organization sites for serialization and trace and trace activities related to US Drug Supply Chain Security Act (DSCSA) compliance.

Area Of Responsibility

• Support cross-functional site team with regards to track and trace systems implementation, setup,

validation, monitoring, and maintenance.

• Project management of projects involving large number of internal and external stakeholders.

• Lead serialization systems issue resolution activities with cross-functional team.

• Ensure manufacturing site(s) connectivity to Sun 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, SOP generation 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.

• 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.

• Harmonization of process followed for packing operations as well as serialization and implement the same at site.

Work Conditions:

Corporate office environment

Manufacturing / Production environment

Warehouse environment

• Environmental related to manufacturing/production environments:
• Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.
• Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
• Odors: Unpleasant smells.
• Gases: Examples include carbon monoxide and ozone.
• Dust: Airborne particles of any kind, such as textile dust, wood, and silica.

Hazards: Conditions where there is danger to life, health or bodily injury such as closeness to moving mechanical parts; working on scaffolding and high places; exposure to burns, radiant energy, explosives, toxic chemicals, and electric shock.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• While performing the duties of this job the employee frequently is required to sit, stand; talk, hear, walk; use hands and fingers to operate a computer, telephone, keyboard and mouse. Light to moderate lifting up to 20lbs. is required.

• Ability to navigate office, lab, and/or plant floor working environments, stands, ambulates, and reaches.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Travel Estimate

Up to 15 %

Education and Job Qualification

• Bachelor of Science degree.

• High proficiency in Microsoft Office – specifically Excel and Powerpoint; Microsoft Office, SAP preferred.

• Having thorough knowledge of CGMP practices.

• Demonstrated excellent communication: verbal, written and presentation skills.

• A self-starter with a hands-on approach and a can-do attitude that can work independently.

• A team building champion driving innovative cross functional synergies.

• Excellent project management and problem solving skills

• The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).

Experience

• Must have good understanding of serialization and track and trace regulations, e.g., US DSCSA, EU FMD, Russia, Brazil, India and GS1 compliance.

• Demonstrated experience of working with serialization systems and L4 solutions desired.

• Significant experience of handling deviations through proper compliance process, investigate packing complaints along with resolutions and implement Corrective and preventive Action.

• Tactical hands on experience of packing operations, technical knowledge of packing line equipment’s.