IT Systems Solutions Specialist
- Experience Level
- Experienced (non-manager)
Truly global Pharmaceutical Company seeks an experienced IT Systems Solutions Specialist.
About the role:
Management, coordination and support of activities relating to the maintenance, development, troubleshooting, auditing and validation of GMP-relevant IT application systems and IT infrastructure components, such as Trackwise, Empower, Tiamo 2.5, WinLab UV, TruScan 2.6.0, TOC DataPro900 0.1.51, Spectrum 2, Lab Network, LabX, SEAL CSFAs, Agilent Baths.
Ensure GMP environment systems and software validation and process compliance with internal policies and external (Data Integrity, FDA, ICH and MHRA) regulations. Ensure QC Systems and data comply with Data Integrity regulations.
Provide support, advice and guidance to systems' end users.
About the role:
- Create, maintain and modify user accounts and passwords on GMP relevant application systems and IT infrastructure components.
- Create and maintain methods in Laboratory Computer systems.
- Validate new software and systems.
- Perform troubleshooting and monitor server space to prevent downtime and unexcepted failures.
- Launch, lead or support project activities linked to the implementation of new or changes to existing Quality IT systems and softwares.
- Run monthly QC project meetings with IT, Validation, QCCCTS and QC to update status of ongoing projetcs.
- Provide technical guidance/advice and training for other team members on the use of systems.
- Communicate with Development in the initiation of new items and products in the Quality Computer Systems
- Complete Data Integrity assessments of all QC systems and data generated by Quality Control.
Skills and experience:
- Excellent knowledge in the field of quality assurance of Computerised Systems including FDA (CFR Part-11) compliance requirements.
- Excellent knowledge of Qualification of IT infrastructure and Validation of Computerised Systems within a GMP regulated environment.
- Thorough knowledge of GMP requirements.
- Strong written and verbal communication skills.
- Project management skills.
- Strong computer skills and knowledge of pharmaceutical quality systems such as, Empower and Trackwise.
- 2 (2)
- Knowledge of SAP regarding set-up of items and certification of test results
- Experience of Pharmaceutical Production and associated equipment and systems.
- Experience using SAP within quality function.
- Training individuals at all levels in Empower, Trackwise, SAP and other associated sytems.