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
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