PE Global is currently recruiting for a Stability LIMS Systems for a leading multi-national Pharma client based in South Dublin.
This is a contract position.
Role:
Position will be required to support future state stability project work stream for the integration of stability business processes and programs through modification and generation of LIMS requirements. The position is designed for direct interaction and support for the stability program's ongoing operations, current and future program and system integrations, and immediate troubleshooting. In order to effectively support the stability end users, this role will need to generate comprehensive user requirements, understand the associated LIMS elements, and be able to identify and assess overall impact to operations. This role will require participating in future state process determination and have responsibility toward identifying areas of alignment to the system. This is a highly collaborative role that requires a strong sense of stability understanding in order to drive the right end user outputs. As required to support ongoing activities, this role may include storing the stability study management and current state LIMS activities.
RESPONSIBILITIES:
1. Support the Senior Manager in identification, documenting, and driving commercial stability user requirements for a future state LIMS system
2. Serve as a point of contact for the stability user group in order to liase with business and process owners and direct management, with the intent on developing, managing, and executing stability strategies related to the future and current state LIMS systems.
3. Serve as a technical expert within the Sample Manager LIMS and Labware systems in order to support mapping multiple current state LIMS processes to a singular future state, centralized LIMS system
4. Support static builds, migrations, and system updates to enhance current stability operations for critical ongoing Run-the-Business requirements
5. Support and or manage user ticket requests to ensure available stability support and completion.
6. Execute and/or manage completion of UAT (for functionality changes)
7. Training stability personnel on LIMS system usage
8. General LIMS user support and initial/basic troubleshooting
9. Maintain and operate within cGMP requirements, including maintaining training status.
10. Perform stability scientist duties, as needed (e.g. stability submission and program strategies, stability protocols, trending, managing product requirements)
11. Perform against the company values: Accountability, Passion, Innovation, Integrity, Urgency, Inclusion.
REQUIREMENTS:
1. Bachelor of Science (BS), at a minimum, with at least 10 years of experience within the pharmaceutical industry: at least 5 years of stability product/program experience and 5 years developing and executing LIMS strategies to support the stability program
2. Must be able to understand stability process, quality, and integrated validated systems, in context of multiple LIMS systems
3. Experience in processing LIMS tickets, demands, and enhancements requiring successful UATs
4. Experience working across departmental and functional lines.
5. Must be able to work across border, cultures and multiple time zones
6. Must be able to operate within a global organization that encompasses different drug product platforms, multiple operational sites, and multiple LIMS systems and platforms
7. Strong understanding of GMP requirements.
8. Familiarity with Data Integrity principles is a requirement.
9. Familiarity with Quality Risk Management is a benefit.
10. Fluency with the French language is a bonus.
Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up to date CV to [email protected]
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
