Business System Owner- Serialization

Job 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