Application Support & Deployment Officer

Company: HireTalent
Location: Kalamazoo
Posted on: January 22, 2023

Job Description:

Job Title: Application Support & Deployment Officer
Job Location: Kalamazoo, MI
Job Duration: 5 Months

Job Description:

• 
  
• The person holding this role is someone who regularly interfaces with business customers.
  
• The recipe author will be on site and become proficient with the standard functionality of MES (Manufacturing Execution System) PharmaSuite and work with production units to convert paper records to EBR (Electronic Batch Record).
  
• The EBR recipe design author will focus on the directly authoring and configuring master batch record and templates, revisions, validation and change controls of EBR Recipes at the Kalamazoo Manufacturing Site.
  
• Assist and Execute supporting SAP Functions BOM, PV and IDOC management.
  
• The recipe author will define and analyze business requirements through meeting with production units and develop detailed designs to meet those requirements.
  
• They will direct the coordination of standard work practices assuring alignment of supporting systems and reports.
  
• They will providing training to production units, audit file monitoring and troubleshooting, as well as on going data management.
  
  
  ROLE RESPONSIBILITIES
  Responsibilities can include but not limited to:
  
  • 
    
  • 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.
    
    
    SKILLS NEEDED
    Skills can include but not limited to:
    
    • 
      
    • Excellent communication and documentations skills.
      
    • A high level of motivation, personal engagement, flexibility and proactive approach.
      
    • Abstract thinking ability for developing technically sustainable, as simple as possible and maintainable recipe designs.
      
    • Self driven and ability to complete objectives within designated timeframes.
      
    • Agile methodology knowledge.
      
    • Technical writing experience.
      
      
      Quality Management and Compliance:
      
      • 
        
      • Ensure compliance of operations to cGMP, safety and *** 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.
        
        
        BASIC QUALIFICATIONS
        
        • 
          
        • Education: Bachelor's Degree
          
        • Experience: 3-5+ years relevant experience
          
        • 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.
            

Keywords: HireTalent, Kalamazoo , Application Support & Deployment Officer, Other , Kalamazoo, Michigan