21 Oct
|
Rishika Health
|
Ahmedabad
21 Oct
Rishika Health
Ahmedabad
Qualified candidate required with 5 years plus experience in pharmaceutical serialization or track & trace.
Roles & Responsibilities
- Implement, configure, and support pharmaceutical serialization and aggregation solutions.
- Manage serialization processes across L1–L5 systems.
- Ensure compliance with global regulations, including US DSCSA, EU FMD, and applicable GS1 standards.
- Integrate serialization solutions with ERP, MES, packaging lines, and external systems.
- Handle EPCIS data exchange, serial number management, and product traceability.
- Troubleshoot serialization, aggregation, data exchange, and system integration issues.
- Coordinate with technical teams, vendors, and clients for implementation and support.
- Prepare technical documentation, validation reports, and SOPs.
- Support system testing, UAT, deployment, and production activities.
- Monitor serialization system performance and resolve operational issues.
Required Skills & Qualifications
- Strong understanding of serialization architecture (L1–L5).
- Knowledge of GS1 standards, GTIN, SGTIN, SSCC, and EPCIS.
- Experience with serialization platforms such as TraceLink, SAP ATTP, Systech, Antares Vision, or similar.
- Understanding of aggregation, commissioning, decommissioning, and reconciliation.
- Familiarity with REST APIs, XML, JSON, and system integration.
- Knowledge of pharmaceutical regulatory compliance and validation processes.
- Strong analytical, communication, and problem-solving skills.
Preferred Skills
- Experience with international pharmaceutical serialization projects.
- Knowledge of ERP/MES integrations.
- Understanding of GxP, GAMP 5, and CSV/CSA validation practices.
- Experience with cloud-based track & trace solutions.
- Client-facing implementation and technical support experience.
Pay: ₹80,000.00 - ₹120,000.00 per month
Perks:
- Provident Fund
Work Location: In person
📌 Pharma Serialisation Specialist (Ahmedabad)
🏢 Rishika Health
📍 Ahmedabad