Serialization Specialist Resume

SUMMARY:

I am a results - driven, proactive, and strategic thinker with project management, analytical thinking, and problem-solving skills. Experienced in business operations, supply chain and customer-focused work within the Pharmaceutical Supply Chain specializing in Serialization requirements, Master Data, ERP systems, and serialization software. I am a passionate and enthusiastic person who enjoys solving complex problems through teamwork and leadership.
Advanced understanding of business processes and regulations in the pharmaceutical industry.
Expertise of global serialization and aggregation regulations including US DSCSA, EU FMD and SFDA.
Adept in GxP compliance environments, including regulatory and customer audit experience.
Experienced working in supply chain and have obtained the APICS Supply Chain Professional .
Superior understanding of SAP ERP and ATTP functionality, data mapping and master data.
Project management experience, specifically in ERP and ATTP systems integrations and upgrades.
Subject Matter Expert for GS1 Standards, which includes ID keys, barcoding and EPCIS.
Extensive experience with work being focused on cross-functional projects including Engineering, Packaging, Global Logistics, Commercial, NPL, QA, RA, and Global External Supply.
Robust understanding of software development life cycle and operational support.
Strong interpersonal skills, including excellent presentation skills.
Proficient with Microsoft Office (Word, Excel, PowerPoint and Visio).

PROFESSIONAL EXPERIENCE:

Confidential

Serialization Specialist

Responsibilities:

Business process owner and SME of Apotex’s L4 Serialization Solution (SAP ATTP).
Project managed multiple integration projects by specifying deliverables, resources, and timelines as required.
Coached and mentored internal stakeholders and departmental staff to foster sound, accurate, and compliant approaches to serialization regulations, as well as GS1 Standards.
Managed all user acceptance testing, validation and change control (QMS) processes to work efficiently.
Managed all risks and issues associated with the customer complaints and technical integrations, as well as developed, planned and project managed solutions (Corrective Action, Preventative Action - CAPA).
Led the implementation of establishing barcode grade quality processes and standards across multiple sites.
Participated in GS1 working groups including Rx Secure Supply Chain, GLN Advisory, and Data Quality workgroups and liaised with customers and other industry trading partners to establish industry best practices.
Qualified SAP ATTP and GS1 trainer responsible for designing, developing, planning, organizing and delivering the required learning courses to support Serialization integration technical .

Confidential

Analyst, Global Supply Operations

Responsibilities:

Developed and implemented a requirements program and documentation to ensure compliance by CMOs to Apotex standards including data exchange, labelling, and barcoding. This involved the business impact analysis of data mapping design, business requirements, and CMO scenarios.
Analyzed and identified areas for serialization process and data quality improvements to meet the demand needs of the business.
Performed data analysis and impact assessment to identify any business impact on existing and new processes and functions. This included CMO/customer on-boarding, and IT integrations.

Confidential .

Co-op Coordinator

Responsibilities:

Supported and managed multiple projects to meet current and emerging global serialization requirements including US, EU, Saudi Arabia, China, Brazil and many others.
Organized and co-chaired executive steering committee meetings for the global serialization program
Coordinated updates to global standard operating procedure and monitored Packaging Line installation schedules.
Completed GTIN (Global Trade Item Number) data gap analysis including the calculation for new and existing SKUs on time to meet global regulatory requirements.

Confidential .

Junior Engineer

Responsibilities:

Specified functional requirements, designed, tested and integrated the components of a photovoltaic cell
Managed the scheduled projects involving Differential Scanning Calorimetry to test and analyze solar energy components and systems.