Serialization Coordinator

Preferred candidate profile

The Serialization coordinator will be responsible to work on the various projects/support. He/ She will work with cross functional teams to assist in getting the solutions for both new and existing system. He/she will support the production activity and requirements for smooth operation. The candidate will have to support the business need and support the business hours i.e., US Time Zone.

Role & responsibilities

• Assist in handling batch rework, reprinting of serial numbers, and reconciliation of serialized data.
• Support CMO/Brand owner requirements with respect layout and designing of layout on bartender, Clarisoft.
• Setup and manage layout server which include creation and configured file.
• Setting up the new product recipe and configuration on OSM and Line master.
• Provide operator instruction, troubleshooting methods, and best practice techniques, for execution by your line operators and supervisors. It is expected that your Operators will learn and execute the steps required to become autonomous in their roles.
• Deliver basic training (system familiarization) to demonstrate and explain face to face functionality of your specific lines or solutions.
• Remote access to Optel line equipment HMIs can be established to provide on time support as per defined SLA.
• Assess configuration and verify functional status of existing Optel solution including Pharmaproof, LineMaster and OSM.
• Prioritize the immediate action items for commercial production and work to establish a sustainable process for product master data, onboarding new customers and managing serialization activities.
• Support in documentation review of IQ/OQ for the any upgrade or changes in the system.
• Support in execution of IQ/OQ qualification documents for the line system.

REPORTING STRUCTURE:

Role reports to: Sr. Manager Serialization

QUALIFICATION:

Bachelor degree in Engineering, Electronic, Instrumentation or related filed. Any automation or process enhancement certificate will be additional.

EXPERIENCE:

• Bachelors degree with 10 years + of professional experience in pharmaceutical industry for serialization. •Hands on experience on Optel Line system along with layout creation. •Experience in OSM with respect to layout, recipe and material master •Customer on Onboarding on OSM and Tracelink. •Communication setup between TTO and TIJ printer.