Global Clinical Supply Chain Application Engineer – Manufacturing Systems

3 weeks ago

Bengaluru, Karnataka, India Astellas Pharma Full time

Purpose and Scope:

A Global Clinical supply chain application Engineer is the Subject Matter Expert focused on the system administration, maintenance and enhancements to facilitate changes to Clinical Supply Chain systems and business processes in a complex Scientific IT landscape to ensure proper operation of GxP and non-GxP systems. Typical systems that support Supply chain management, clinical trial management, Forecasting and Inventory management and Temperature Excursion management within the Manufacturing Clinical Supply Chain optimization are part of your knowledge, experience and skillset. Additional skillset and knowledge is required for data integration and transformation tools preferably Oracle EDQ.

Responsibilities and Accountabilities:

  • Be the first point of contact for key users in the Clinical Supply Chain systems and provide technical support, triage issues and requests.
  • Work closely together with your direct colleagues and team members to support multiple Clinical Supply Chain globally.
  • Be the subject-matter expert for the lab systems during inspections and audits.
  • Be responsible for daily administration, maintenance and user management (e.g. create and manage roles and support user access review request) of systems such as Smart Supplies PMD, Smart Supplies SSF, Temperature Excursion system built on Appian and related data interface support. Facilitate and/or initiate enhancements and changes to the systems in close collaboration with the vendor.
  • Perform month end and year-end activities as required to support clinical supply chain business processes.
  • Help and support testing and validation during implementation, upgrades, etc. of all systems following SLC process and documentation.
  • Conduct training sessions to users to ensure proper use of the laboratory systems.
  • Regularly monitor the performance of the lab systems, identify bottlenecks, and implement optimizations to improve efficiency and user experience.
  • Ensure seamless integration in between the Clinical supply chain systems and with external sources to enable data flow between systems.
  • Manage and ensure proper operation of GxP and non-GxP lab systems by adhering to Astellas global and local procedures and guidelines.
  • Work collaboratively with team members within the subdivision and across other digital and business units
  • Actively participate in and contribute to various initiatives like process improvements and set up/improve the Scientific IT landscape
  • Contribute to the ongoing realization of Value from these lab systems through continuous integration and deployment.
  • Engage in continuous learning and professional development to stay abreast of the latest trends and technologies in the specific area of expertise.
  • Contribute innovative ideas and approaches to enhance project outcomes and digital capabilities.
  • Employ analytical and problem-solving skills to overcome project challenges and deliver effective solutions
  • Agile mindset with knowledge and experience using Azure DevOps for project management.

Required Qualifications:

  • Bachelor's degree in information technology, Supply Chain Management, Pharmacy, or a related field; advanced degree preferred.
  • Minimum of 3+ years demonstrated experience in the scientific IT area, preferably in pharma/biotech environments.
  • Ability to work effectively in a team environment.
  • Excellent communication skills, both written and verbal (English (or English/Japanese for JP region)
  • Proficiency in clinical supply chain management software and database systems (e.g., Oracle, Smart Supplies etc.).
  • Strong analytical skills with the ability to interpret complex data sets and generate actionable insights using analytical and ETL tools preferably Oracle EDQ, SQL, Postman etc.
  • Agile mindset with experience using Azure DevOps for project management.
  • Solid experience in SLC validation process with GxP systems and related documentation
  • Ability to multi-task as it relates to day-to-day responsibilities.
  • Agile and adaptable to changing environments and initiative scopes.
  • Demonstrated experience working with business to define Epics/user stories/features, as well as conducting impact analysis.
  • Able to support technical upgrade by conducting impact assessment, addressing any issues, support testing, and document changes per the System Life Cycle (SLC) processes in Astellas.
  • Support system deliverables and provide technical and functional feedback during internal and external system audits.
  • Work closely with the internal privacy and security team to assess Personal Information requests and act according per the privacy laws applicable to the region.
  • Maintain and report any issues and communicate effectively to all stakeholders during project/enhancement phase, service disruptions, and during technical upgrades.
  • Lead without authority and be escalation point for any customer issues.
  • Mandatory local language to communicate to business Clinical Supply Chain and Site management

Preferred Qualifications:

  • Agile Champion: Adherence to DevOps principles and a proven track record with CI/CD pipelines for continuous delivery
  • Preferred knowledge in Appian platform and Qlikview
  • Present technical and/or functional solutions based on the business requirement of the Manufacturing system.

Working Environment

  • This position is hybrid (on-site/remote) and based in India.
  • At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.

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