What are the responsibilities and job description for the Serialization Business Analyst position at Aveva Drug Delivery Systems Inc?
Job Summary:
SME for the Serialization systems, machines and processes. Responsible for collaborating with cross-functional departments and colleagues to expand the current Serialization System.
Job Responsibilities:
Logging, updating, resolving all Serialization support requests including:
- New Accounts
- Change Access
- Enhancement requests
- Password resets
- System issues / errors
- Process Optimizations
- Customer complaints relating to serialization issues
Creation/maintenance of all Serialization SOPs (capturing changes in process, editing based on user feedback, driving approvals, the change control process, consulting with SMEs)
Training all current and new users across every functional group.
Maintaining license count, security role matrix, and approval hierarchy
Professionally communicate with technical and non-technical staff in written, oral, and formal presentations
Engage with Information Systems, IT, Operation and Validation teams to manage the systems, during design sessions, or peer review sessions while simultaneously maintaining the operational status of the functionality.
Project coordination / management for related IT activities
Perform all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence.
Perform all work in accordance with all established regulatory, compliance and safety requirements.
All other duties as assigned.
Job Requirements:
- Complete knowledge and understanding of GS1 and DSCSA regulatory requirements is imperative
- Hands-on experience working with GS1 and DSCSA requirements is a must
- Bachelor's degree in IT or Business or comparable work experience
- Highly motivated professional with 5 plus years of combined experience in IT, operations and/or business processes.
- Exceptional curiosity for analyzing and interpreting data, with a focus on problem identification and resolution
- Strong presentation skills to facilitate communication of initiatives in various forums - large employee meetings and briefings with senior leadership
- Proven strong organizational, time management, and project management skills. Demonstrated experience in managing project activities
- Strong organizational, interpersonal and communication skills - excellent command of the English language, both written and verbal
- Ability to accept direction and developmental guidance from Manager
- Ability to be a self-starter, work independently and manage multiple priorities in a fast-paced and changing environment
- Working knowledge of cGMP, Part 211
- Proficiency with Word, Excel, JDE and statistical software.
5 years experience in related field
In depth knowledge of GSI and DSCSA regulations
Working knowledge of pharmaceuticals packaging operations
Optel / Jekson serialization equipment and systems a plus
