In this hands-on role, this person will be responsible for partnering with Technical Operations, Finance, Learning and Development (L&D) and other Jazz functions to identify, design, implement and support new business capabilities, together with providing key tier 2 support in relation to the technology systems which enable these functions. This person will deliver business analysis, Security, data management, and computer system validation activities which adhere to Jazz’ policies, SOP’s and best practices for GxP and Non-GxP systems to support all aspects of the organization’s operations.
Responsible for, but not limited to:
- Partner with Technical Operations, Finance, Learning and Development (L&D) and other Jazz functions to understand objectives, priorities and to assist in development of business capability roadmaps
- Work collaboratively with IT teams, internal business partners and external vendors to identify, understand, implement and support new business capabilities where appropriate.
- Identify and implement process and/or system changes that improve effectiveness of business areas.
- Provide level 2 Support for the Technical Operations systems.
- Reporting, processing and resolving any incidents reported by end users in accordance with Jazz standard processes.
- Liaise with the vendor’s Technical Support team(s) to determine and implement incident resolution in a timely manner.
- Drive the implementation of process improvements / configuration changes identified by the business in accordance with Jazz standard Change Control processes.
- Coordinate the implementation of Patches / Upgrades etc. with the vendor to minimize impact to ongoing projects and resources. Ensure proper testing and communications are conducted.
- Collaborate with global QA, IT, and business functions to ensure successful planning, execution and delivery of validation projects following the Jazz CSV framework, methodology, and procedures.
- Collaborate to develop and execute validation test protocols, such as IQ/OQ/PQ, in accordance with the validation master plan and other applicable standard operating procedures (SOPs).
- As System Owner work collaboratively with other System owners, Jazz QA and CSV to ensure that GxP systems are operating as expected and are maintained in accordance with regulatory requirements and Jazz ITOP’s
- Work with Business Process Owners and Governance Council to identify and prioritize any process / system enhancements, working with Jazz internal teams to ensure timely implementation
- Ensure that the learning management system (LMS) meets all regulatory compliance needs and ensure data accuracy and integrity
- Maintain the Service Level Agreement and Quality Technical Agreement with the system Vendors
- Maintain system security and data privacy, of systems in scope, in accordance with current Jazz policies and applicable regulations.
- Work directly with Technical Operations System Administrators and SuperUsers to ensure compliance and productive working relationships.
- Assist with troubleshooting quality / functionality issues associated with the systems
- Maintain a positive and collaborating working relationship with the system vendors
- Foster a positive employee relations environment and a culture of continuous improvement, partnership, and teamwork through the use of good and consistent management principles.
- Bachelor degree in Science, Computer Science or equivalent experience required.
- Experience (3-5 years) working in support of enterprise wide systems in a Business analyst and/or Technical role, with implementation and operations support experience
- Understanding and demonstrated experience of, QMS systems and processes, including CAPA/Deviation, Product Complaints, Audit, Document Control and Change Management.
- Understanding of Serialisation solutions in support of US DSCSA and EU FMD requirements. Knowledge of Axway Track and Trace an advantage.
- Knowledge of Pharmaceutical Quality Systems, Computer system/software validation, and Software Development Life Cycle (SDLC) Management methodologies
- Knowledge of LMS particularly in Pharma industry. Knowledge of Saba platforms an advantage.
- Previous experience as System Owner for GxP System(s).
- Able to work independently as well as with global cross functional teams and time zones made of internal customers and external service providers
- Demonstrates a strong desire to understand business needs and improve business processes
- Highly organised, with exceptional time management and prioritisation skills
- Strong desire to excel as an individual contributor and be able to execute deliverables with minimal supervision.
- Critical thinking and evaluation of process problems
- Excellent verbal and written communication skills
- Patient and results orientated
- Collaborative team player
- Strong work ethic with a flexible and adaptable approach
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours in support of the Jazz global organization.
- Occasional public contact requiring appropriate business apparel.
Jazz Pharmaceuticals is an Equal Opportunity/Affirmative Action Employer
Jazz Pharmaceuticals is an Equal Opportunity Employer.