Job Details

  • Title: EBR Recipe Design Author
  • Code: RCI-24858-1
  • Location: Kalamazoo, MI 49001
  • Posted Date: 05/13/2022
  • Duration: 12 Months
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  Job Description

Position Description

 

ROLE SUMMARY

  • The EBR Recipe Design Author will focus on the design, preparation, revision, validation and change controls of EBR Recipes at the Kalamazoo Manufacturing Site.
  • They will have thorough knowledge of MES.
  • Assist and Execute supporting SAP Functions BOM, PV and IDOC management.
  • The recipe author will coordinate supporting functional departments for smooth production activities and ensure all performed activities comply with respective procedures.
  • They will direct the coordination of standard work practices assuring alignment of supporting systems and reports.
  • Providing training, audit file monitoring and troubleshooting, as well as on going data management.
  • As a Business Systems Professional, they are responsible for SCO SOP management for their area.
  • They will reassess the business processes at intervals to eliminate non-value-added activities and drive continuous improvement.
  • In addition will also support other Business Operating Systems owned by the Supply Chain Business Systems Team and various interfaces as needed and required.

 

ROLE RESPONSIBILITIES

Responsibilities can include but not limited to:

Operations:

  • Design, preparation/revision of Electronic Batch Records (EBR).
  • Supporting end users on EBR execution/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/new batch records.
  • Handling of SAP/EBR related issue and shop floor support.
  • 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.

Quality Management and Compliance:

  • Ensure compliance of operations to cGMP, safety and Client integrity principles at all stages of activity
  • To participate in internal & external (regulatory & non-Regulatory) audits.
  • Assist Manager in controlling tracking and periodic EBR procedure updates and manages emergency changes appropriately.

Training:

  • To attend the training of all applicable procedures as per schedule.
  • Training the team on relevant procedures and getting trained on respective area of work.
  • To develop content for AMPS EBR training to new hires and refresher training as needed to end users.

 

Education: Bachelor's Degree

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.

Language Skills:

  • Effective oral and written communications skills

PREFERRED QUALIFICATIONS

  • Pharmaceutical experience
  • Certifications: M1, Yellow Belt and/or APICS
  • Computer Skills: HTML, Java, or object oriented programming
  • Focused in Systems Analyst/Data Management.