Business System Owner- Serialization
India Permanent Posted on Apr. 03, 2025 Closing on Apr. 25, 2025Job title: Business System Owner- Serialization
Location Hyderabad
Job type: Permanent
Main responsibilities:
Administration and configuration
Conduct and document the system tests (User Acceptance Tests, Non-Regression Tests) in case of CMO/Toll partner on-boarding, new features, upgrades of Opella serialization systems (Tracelink/Track4)
Perform the configuration and master data setup in Opella serialization systems
Perform the technical on-boarding for CMO, affiliate partner and Toll customers.
Perform day to day monitoring of serialization data
Establish dashboard and KPIs to evaluate system performance
Assist in any maintenance of serialization systems including the troubleshooting and resolution of routine issues as part of application maintenance.
Assist with the implementation of new enhancements and upgrades to existing systems
Contribute to prepare and maintain Standard Operating Procedures (SOPs), Work Instructions related to serialization systems.
Handle alerts management for EMVO and alerts pertaining to Toll customers
Manage Product master data upload activity to EMVO
Supply continuity
Liaise with different stakeholders like External Manufacturing Supply, Quality, Regulatory teams, I3PS organization, Contract Manufacturing Organization (CMO), markets business teams to ensure business continuity in markets concerned by serialization and aggregation.
Continuous improvement
Propose and implement process upgrades and efficiency improvements
Business Service owner
Accountable for the quality of the service to Business customer
Requirements:
Minimum of 7+ years of experience working in Pharma Serialization and domain
Knowledge of serialization regulatory requirements for EU, RU, Gulf and China
Good knowledge of Quality Management, Industry standards, regulations (GxP, SOX, Data Privacy, etc.), and trends
Adaptability to a changing and highly dynamic work environment
Strong Analytical and Problem-solving skills
Excellent communication and interpersonal skills to build relationships with stakeholders and articulate complex technical concepts
Fluent in English (written and spoken)
Work autonomously and execute complex activities and capacity to anticipate and report any alert with proposed solution/risk mitigation
Service and results oriented
Manage relations with vendor and service providers as required to improve the operational excellence
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