Vacancy expired!
Pay: $35-85ROLE RESPONSIBILITIES
- Design, preparation, and revision of Electronic Batch Records (EBR).
- Supporting end users on EBR execution and usage.
- Manage EBR design and configuration changes, change control, updates, process reviews and alignment with associated documentation used to the continuity plan.
- Facilitate lead and participate in process mapping of business processes
- Be the first point of contact for electronic batch record manufacturing issues.
- Escalation of Electronic manufacturing execution issues to Subject matter expert or supporting team.
- Having thorough knowledge of manufacturing execution system (MES), recipe design, baseline configuration, writing and executing functional verification reports.
- Conducting trainings to executing personnel on EBR system when upgrades are made to the system or recipes.
- Handling of Shop floor troubleshooting in SAP- AMPS interface for Electronic Batch Records.
- Tracking of AMPS recipes revision as per revised and new batch records.
- Management of IDOCs
- BT ticket follow ups and ensuring its resolution with EBR Issues.
- Coordinate supporting functional departments for smooth operation of production activities when reviewing and developing recipes.
- Ensure all the performed activities comply with respective procedures.
- Initiating change controls related to documents, equipment. Ensuring their closure and implementation of changes within specific time.
- Identify deviations/exceptions and escalate to manger by appropriate procedures.
- Adherence to safety procedure/GMP & GDP practices.
- Reassess and participate in an agile change environment to enhance the process at intervals to eliminate non-value-added activities and drive continuous improvement including supporting projects and deployments.
- Participate in cross functional teams to support, enhance, and upgrade AMPS
- Lead or Participate in Projects/Deployments
- Impact assessment
- Master data clean-up
- Recipe Design and Authoring
- Testing
- SOP Updates
- BCD Updates
- Functional Verification Testing
- Writing and implementing protocols
- Training
- They can also assist in the work required to train, execute, track and reporting duties for other colleagues of the Business Systems Support team.
- Education: Bachelor's Degree
- Experience: 3-5+ years relevant experience
- MES Systems Support
- Highly Preferred Computer Skills: EBR Recipe Design and Authoring, Pharmasuite, AMPS (MES), SharePoint Proficiency in Microsoft office suite products (Word, Excel, Power point), QTS or Experience working in Quality Tracking Systems.
- Pharmaceutical experience
- Certifications: M1, Yellow Belt and/or APICS
- Computer Skills: HTML, Java, or object oriented programming
- Focused in Systems Analyst/Data Management.