Varitec Consulting is looking for an experienced Senior Serialization Analyst with strong expertise in pharmaceutical serialization and traceability solutions. The ideal candidate should have hands-on experience working with TraceLink and rfXcel platforms and possess deep knowledge of US DSCSA regulations, serialization operations, EPCIS transactions, master data management, exception handling, and customer communications.

The candidate will play a key role in supporting global pharmaceutical customers by managing production support activities, customer onboarding, regulatory compliance, troubleshooting serialization issues, and collaborating with internal and external stakeholders.

Roles & Responsibilities

- Provide L2/L3 production support for TraceLink and rfXcel serialization applications.
- Support day-to-day serialization operations and resolve production issues.
- Perform Master Data Management activities including GTIN, GLN, Packaging Hierarchy, Product Configuration, Market Configuration, and Trading Partner setup.
- Support customer onboarding for Manufacturers, CMOs, Distributors, Wholesalers, and 3PL partners.
- Monitor, analyze, and resolve EPCIS transaction failures and data synchronization issues.
- Handle serialization exceptions and coordinate issue resolution with customers and business partners.
- Support US DSCSA distribution workflows, verification requests, saleable returns, and product traceability.
- Analyze EPCIS XML files and troubleshoot data transmission and integration issues.
- Perform Root Cause Analysis (RCA) and implement preventive actions.
- Coordinate with Packaging, Warehouse, ERP, Supply Chain, and Quality teams.




- Communicate effectively with global customers through email, meetings, and incident management tools.
- Prepare SOPs, knowledge articles, operational reports, and technical documentation.
- Participate in release validation, testing, and deployment activities.
- Mentor junior team members and support knowledge-sharing initiatives.

Required Skills

Mandatory Skills

- TraceLink
- Pharmaceutical Serialization
- US DSCSA
- EPCIS
- Master Data Management
- Exception Handling
- Customer Communication
- Customer Onboarding
- Production Support
- Trading Partner Management
- XML
- L3/L4 Serialization Architecture

Technical Knowledge

- Hands-on experience with TraceLink (Mandatory)
- Hands-on experience with rfXcel (Preferred)
- Understanding of serialization architecture and supply chain integrations
- Experience working with production support and managed services

Regulatory Knowledge

Strong understanding of:

- US DSCSA
- Distribution Workflows
- Product Traceability
- Verification Router Service (VRS)
- Saleable Returns
- Trading Partner Onboarding

Exposure to EU FMD, Russia Chestny ZNAK, Brazil ANVISA, Saudi SFDA, or other global serialization regulations is an added advantage.

Desired Candidate Profile

- 5 to 10 years of experience in Pharmaceutical Serialization.
- Minimum 3 years of hands-on experience in TraceLink.
- Experience supporting global pharmaceutical customers.
- Robust analytical and troubleshooting skills.
- Excellent verbal and written communication skills.
- Ability to independently manage customer interactions and production incidents.
- Ability to work effectively in a fast-paced, customer-focused environment.
- Willingness to work in India shift with overlap during US business hours.

📌 Senior Serialization Analyst | TraceLink | Lspedia | US DSCSA (Hyderabad)
🏢 VariTec Consulting
📍 Hyderabad