Manager - Track & Trace

Responsibilities

• Act as the subject matter expert for serialization and track and trace activities across multiple global markets including US DSCSA and EU FMD.
• Support cross-functional site teams with the implementation, setup, validation, monitoring, and maintenance of track and trace systems.
• Lead issue resolution for serialization systems and ensure manufacturing site connectivity to Sun L4 systems.
• Collaborate with end-users to define use-cases and conduct relevant serialization training.
• Manage change control processes and review technical/validation documents provided by vendors.
• Facilitate vendor assessments, risk assessments, and the generation of SOPs.
• Perform serialized product alert analysis and participate in investigations regarding product complaints.
• Optimize operational capex and evaluate vendors for ideal serialization and aggregation equipment.
• Drive process simplification and automation projects to increase productivity and reduce manual errors.

Requirements

• Bachelor’s degree in a science-related subject.
• 15+ years of relevant experience in pharmaceutical operations or related fields.
• Proven expertise in project management involving large numbers of internal and external stakeholders.
• Deep understanding of global Serialization and Track and Trace regulations (US DSCSA, EU FMD, GS1 compliance, etc.).
• Technical knowledge of packaging operation processes, packaging materials, and packaging equipment.
• Hands-on experience with line serialization systems and L4 solutions.
• Strong knowledge of cGMP practices and experience handling deviations and CAPA.
• High proficiency in MS Office, particularly Excel and PowerPoint.
• Excellent verbal and written communication skills.

About the Company

Sun Pharmaceutical Industries Ltd is a leading global pharmaceutical company dedicated to providing high-quality medicines and fostering an environment of continuous growth and innovation.