- Experience Level
- Experienced (non-manager)
Seeking an experienced Quality Engineer to take ownership and management of tasks around IT and Lab systems, QMS, Digiital systems, compliance, CAPA process, technical writing and quality documentation in a managed service environment.
* Technical writing of IT Deviations, CAPAs, Change Controls, SOPs and other Departmental/System Quality Documents in compliance with regulatory and corporate requirements
* Assist IT personnel in technical writing/responding to CAPAs (including remediation activities), Change Controls, SOPs and other Departmental/System Quality Documents in compliance with regulatory and corporate requirements
* Assists IT personnel in technical writing/responding to Deviation/Events including detailed event investigation and root cause analysis in compliance with regulatory and corporate requirements
* Assists IT personnel in interactions with Quality Assurance personnel and the Quality Management System.
* Successfully navigate the Electronic Quality Management System and work with other impacting departments to ensure IT Deviations, CAPAs, Change Controls, SOPs, etc are monitored, progressed and closed in-line with agreed timelines
* Assists IT personnel in participating in and successfully navigating through the electronic Quality Management Processes
* Represents IT at meetings relating to assigned items
* Assists IT SME's during internal and external audits
Knowledge and Skills:
* Excellent understanding of Quality, QMS, compliance, technical writing ability and communication skills
* Knowledge and experience of working in a cGMP regulated environment
* Excellent attention to detail, ownership of process and tasks, computer skills, and ability to adapt to new systems/technologies
* Ability to work independently with only high level guidance and supervision
If you are interested and feel you have the right skills then please apply to this role.
Gi Group Pharmaceuticals provides a tailored Account Managed Service and dedicated Pharmaceutical recruitment team and partners with many different Pharmaceutical and Biotechnology clients throughout the globe and the United Kingdom.