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Omais Siddiqui

@omaissiddiqui

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I deliver compliant pharmaceutical serialization integrations, validation, and DSCSA supply chain operations.

United States

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What I'm looking for

I'm looking to lead pharmaceutical serialization, system integration, validation, and compliance initiatives that strengthen traceability, data integrity, and regulatory readiness across global supply chains.

I'm delivering end-to-end DSCSA serialization implementation at Aveva Drug Delivery Systems, including Optel Verify, Optel Bridge, OSM connectivity, EPCIS troubleshooting, and CMO/distributor onboarding for Baxter, Padagis, and Ingenus Pharmaceuticals.

Across Precision Dose Pharmaceuticals, Spectrum Pharmaceutical Distributors, and CityMed Pharmaceutical Distributors, I've deployed and supported Rfxcel, LSPedia One Scan, Edge, TraceLink, and ERP integrations. I manage master data, GTIN/SGTIN mapping, EPCIS exchanges, CSV testing, SOPs, change control, user access, compliance reporting, and DSCSA milestones.

Previously at VISIOTT Traceability Solutions and Zauq Group, I integrated L2 hardware and L3-L4 track-and-trace systems, validated IT systems, supported production lines, and trained end users. I work across global pharmaceutical traceability requirements including DSCSA, EUFMD, Tatmeen, ANVISA, NHRA, Turkish ITS, 21 CFR Part 11, GS1, and GAMP.

Experience

Work history, roles, and key accomplishments

Current

Serialization Business Analyst

Current

Aveva Drug Delivery Systems

Jul 2025 - Present (1 year 2 months)

Responsible for end-to-end project implementation of DSCSA serialization project at Aveva Miramar site, including CMO/distributor onboarding and EPCIS error handling.

DSCSA EPCIS Optel L4 Optchain Serialization Project Management CSV SOPs AS2 SFTP

IT Serialization Process Specialist

Varitec Consulting

Oct 2024 - Jul 2025 (9 months)

Provided operational support and technical troubleshooting for Rfxcel L4 serialization software, managed full lifecycle deployments, and ensured regulatory compliance.

Rfxcel LSPedia EPCIS DSCSA CSV GxP Jira Monday.Com Excel Smartsheet LDAP Bartender GS1 21 CFR Part 11

Technical Engineer

VISIOTT Traceability Solutions

Jul 2020 - Aug 2024 (4 years 1 month)

Assisted in integration of L2 hardware and L3-L4 track & trace software, managed client relationships, and led projects ensuring compliance with regulatory standards.

Zoho CRM Proposify Monday.Com IQ+Data Quality 21 CFR Part 11 GS1 GAM EUFMD DSCSA ANVISA MDLP TATMEEN NHRA Turkish ITS

Project Consultant

Zauq Group

Apr 2018 - Dec 2019 (1 year 8 months)

Executed on-site installations and validation tests for serialization systems, provided troubleshooting, and conducted training on Pharma Secure PSID and L2 line manager software.

TeamViewer PSID L2 Line Manager Serialization Project Management Validation