Job Summary The SME for Track & Trace Serialization will be responsible for supporting and managing enterprise serialization and traceability systems across manufacturing, packaging, warehousing, and supply chain operations. The role will oversee day-to-day operations, incident management, implementation of serialization projects, regulatory compliance activities, and integrations between Level-4/Level-3/Level-2 systems including TraceLink, Optel OSM, SAP, and Packaging Line Controllers.

The incumbent will collaborate with business stakeholders, quality assurance, regulatory affairs, supply chain, manufacturing, and external partners to ensure uninterrupted serialization operations and regulatory compliance across global markets.

Key Responsibilities

Serialization Operations Support

- Provide L2/L3/L4 application support for Serialization and Track & Trace platforms.
- Monitor daily serialization activities and ensure smooth production execution.
- Manage product onboarding, commissioning, aggregation, shipping, and reporting activities.
- Support issue investigation, troubleshooting, and root cause analysis of serialization incidents.
- Coordinate with vendors and service providers for issue resolution.

System Administration & Compliance

- Manage user access, role assignments, and periodic access reviews.
- Ensure compliance with GxP, 21 CFR Part 11, Annex 11, GAMP5, and Data Integrity requirements.
- Support audit readiness and inspections related to serialization systems.
- Maintain system documentation including SOPs, Work Instructions, Risk Assessments, Validation Documents, and Change Controls.




- Participate in periodic reviews and compliance assessments.

Project Implementation

- Lead deployment of serialization solutions for new customers and markets.
- Support system upgrades, enhancements, and integrations.
- Coordinate validation and qualification activities for serialization applications.

Integration Management

- Support integrations between:
- TraceLink Level-4 Platform
- Optel OSM Level-3 Platform
- SAP
- WMS
- Packaging Line Systems
- SiteMaster/MES Systems
- Analyse interface failures and ensure timely resolution.
- Monitor data exchanges and transaction processing.

Partner & Regulatory Connectivity

- Support onboarding and connectivity with CMOs, Customers, Distributors, and Regulatory Agencies.
- Manage EPCIS data exchange and regulatory reporting.
- Support DSCSA, EU FMD, UAE Tatmeen, Australia, and other country-specific serialization regulations.

Continuous Improvement & COE Development

- Contribute to the establishment of Serialization Center of Excellence (COE).
- Develop best practices, governance models, and standard operating procedures.
- Conduct user training and knowledge-sharing sessions.
- Drive process optimization and automation initiatives.

Required Technical Skills

Serialization Platforms

- TraceLink




- Optel Open SiteMaster (OSM)
- Optel Tracksafe

Enterprise Systems

- S4 HANA
- WMS Integration
- MES Integration

Compliance & Validation

- Computer System Validation (CSV)
- GAMP5
- 21 CFR Part 11
- EU Annex 11
- Data Integrity Requirements
- Change Control Management
- Risk Assessments (FMEA/FMECA)

Technical Knowledge

- XML
- EPCIS
- Web Services/API Integrations
- SQL Queries
- Interface Monitoring
- Incident Management
- Servers

Educational Qualification

- Bachelor's Degree in Engineering, Pharmacy, Computer Science, Information Technology, or related discipline.

Experience

- 7 to 10 years of overall experience.
- Minimum 5 years of hands-on experience in Pharmaceutical Serialization and Track & Trace systems.
- Experience supporting global serialization operations across multiple markets.
- Experience in regulated pharmaceutical manufacturing environments.

Preferred Competencies

Functional Competencies

- Serialization and Aggregation Processes
- Supply Chain Traceability
- Pharmaceutical Manufacturing Operations
- Regulatory Compliance
- Vendor Management
- Project Management

Behavioural Competencies

- Robust Analytical Skills
- Problem Solving
- Stakeholder Management
- Communication Skills
- Leadership Potential
- Customer Focus
- Ability to work under pressure during production-critical incidents

Preferred Industry Experience

- Pharmaceutical Manufacturing
- Life Sciences
- Contract Manufacturing Organizations (CMO)
- Pharmaceutical Supply Chain & Distribution
- Global Serialization Programs

📌 Track & Trace SME (Deputy Manager) (Hyderabad)
🏢 Granules India
📍 Hyderabad