- Administrate and maintain QC Laboratory systems such as eLIMS, LES, Empower 3, SDMS and Softmax Pro
- Providing day to day operational & training support for laboratory systems
- Completion of necessary software systems documentation reviews including periodic reviews, data integrity reviews and SOP updates.
- Creating and managing Empower projects, user accounts, instrument methods, method sets, report methods and processing templates
- Interacts and represents the site on Global COEs related to laboratory systems.
- Ensure laboratory systems are compliant with the data integrity requirements of all applicable regulatory guidelines
- Author, review and approve change controls, CAPAs, laboratory investigations, deviations, SOPS and work instructions, qualification protocol, reports etc
- Anticipates and plans for future requirements in the area.
- Deals with events/ deviations in an accurate and timely manner.
- Identifies opportunities to improve the services provided e.g. new technologies, improved vendor processes, cost, quality etc.
- Supports QC where appropriate in meetings and other communications with regulatory authorities, industry meetings, etc.
- Deputizes for the supervisor and other ream members as appropriate.
- Collaborates across multiple lab groups and with other Janssen sites
- Developing and qualifying the electronic data management processes for the QC team
- BSc Hons (or Higher) in a Science or related discipline.
- A minimum of 2 years' experience in a similar role within a laboratory environment
- Excellent social and communication skills
- Working knowledge of Current Good Manufacturing Practices (cGMP), 21 CFR Part 11, Annex 11, Compliant GxP Computerized Systems (GAMP5), service management, IT project lifecycle and other regulatory requirements or policies
- Self-driven and keeps up to date with regulatory, technical developments within the industry.
- Focus on patients and customers at all times.
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