Senior System Management Consultant with GXP
1 month ago
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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