- Title: Business Systems Analyst
- Code: RCI-20190-1
- Location: Kalamazoo Michigan (MI) 49001
- Posted Date: 01/11/2021
- Duration: 12 Months
- Name:Nirav Soni
- Email: Nirav.email@example.com
- Phone: 908-704-8843 ✖ 239
Responsibilities can include but not limited to:
- Preparation/revision of Electronic Batch Records (eBR) base on the approved Validated Documents.
- Supporting end users on EBR execution/usage.
- Be the first point of contact for electronic manufacturing issues.
- Escalation of Electronic manufacturing execution issues to Subject matter expert or supporting team.
- Having thorough knowledge of manufacturing execution system (MES).
- Conducting trainings to executing personnel on EBR system.
- Handling of Shop floor troubleshooting in SAP- AMPS interface.
- Tracking of AMPS recipes revision as per revised/new batch records.
- Assists in Development and/or Creates/Manages Bill of Material (BOM) and production version (PV) in SAP.
- Handling of SAP/EBR related issue and shop floor support.
- Management of IDOCs
- BT ticket follow ups and ensuring its resolution with EBR Issues.
- Handling of Manufacturing label management (MLM) system.
- Coordinate supporting functional departments for smooth operation of production activities.
- 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 and GxP practices
Quality Management and Compliance:
- Ensure compliance of operations to cGMP, safety and integrity principles at all stages of activity.
- Assist in Audits as a SME
- Assist Manager in controlling tracking and periodic EBR procedure updates and manages emergency changes appropriately.
- Training the team on relevant procedures and getting trained on respective area of work.
- To develop and provide AMPS EBR/SAP/MLM training to new hires and refresher training to end users as required.
*****The role will be primarily on 1st shift (approximately 8AM – 4:30PM). However, in order to support the site and “Run the business” may require occasional off shift and weekend support for operations in a 24X7 Operation.
- Bachelor's Degree – CIS, ISM, Business, Engineering, Science or Related Field.
- Experience: 2-5+ years pharmaceutical industry experience
- Computer Skills: Business System Execution and Data Management (i.e. SAP, MES) and SharePoint. Proficiency in Microsoft office suite products
- Language Skills: Effective oral and written communications skills
Physical Demands/Work Environment: Normal Office however, due to the Pandemic primarily will be providing remote support with occasional onsite work as required.