Senior System Management Consultant with GXP

1 month ago


India QAAgility Technologies Full time

Job Title: Senior System Management Consultant with GXP & ATTP Knowledge


Job Type: Remote


Experience:

  • 8+ years of overall IT experience
  • 4 years of relevant experience
  • Good to have - SAP System Experience, Agile knowhow.
  • 4+ years of experience in Pharmaceutical industry in GxP areas with exposure to regulatory affairs


Mandatory Skills (Must-Have):

  • Strong expertise in System Management with GXP (Good Practice) standards
  • Advanced knowledge of ATTP (Advanced Track and Trace for Pharmaceuticals)


Optional Skills (Good to Have):

  • Familiarity with other relevant system management tools and technologies
  • Experience in pharmaceutical or life sciences industry
  • Strong problem-solving and analytical skills
  • Excellent communication and documentation skills


Responsibilities:

  • This position holder primarily plays the role of System Manager for managing the SAP
  • GBT (GxP & Business Critical), SAP ATTP (GxP & Business Critical), Open Text and UDI
  • Systems covering maintenance and support planning.
  • Work closely with project team on Business Application Onboarding activities etc.
  • Also responsible for GxP systems authorization tasks as relevant
  • System Budget planning and management
  • Periodic System Management Activities
  • Ensure that the IT system complies with internal & external requirements to ensure validated state
  • Supervising the day-to-day usage, operation and maintenance of the computer system
  • Contracting services from suppliers and vendor as needed
  • Validation of Computer systems and application service
  • IT Security Procedure
  • Prepare Requirement Specification for Computer Systems
  • Manage the Configuration in IT
  • Manage Test in IT
  • Manage users of Computer Systems
  • Manage Computer Systems Risks
  • Manage IT Incidents
  • Major Incident and Disaster Recovery in IT
  • Manage System Budget including tracking of all expenses incurred in current year
  • (planned, adhoc), future planning, system contracts and keeping all stakeholders
  • informed about status and deviations if any.
  • Manage System Transition as directed by management.
  • Plan & participate in release & upgrade schedule, technical information (system
  • landscape) surveillance, validate new functionality/project influence on current set-up.
  • Represent system in connection with audits and inspections.



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