Quality Assurance Technical Officer
Our Client in the Co Monaghan area have a requirement for QA Technical Officer working in the QMS & Operational Compliance Department. The role will be joining a newly established quality team. For more information please contact Adam Cromwell, or see our website.
- Liaising with various departments and coordinating regulatory and packaging change controls.
- Initiating and updating of packaging specifications with the co-ordination of old/new packaging.
- Review of all orders on a daily basis against the database to ensure all changes are implemented prior to presentation being scheduled.
- Generation and maintenance of pack models and packaging codes on the Database.
- QA Review of batch documentation i.e. PCR and SPRS for all Presentations manufactured and/or packaged on site.
- Monitor Suite Right First Time Key Process Indicators.
- Ensure that traceability of all documentation received into the QA Office is maintained and respectively filed within the QA Department and coordination of archiving of relevant quality records.
- Liaise with all relevant departments to ensure all supporting documentation is further processed in a timely manner to support batch release and meet customer promise dates.
- Assist the QA Manager in the investigation of Deviations and management of CAPA, change control, Effectiveness Checks and Customer complaints on Trackwise system as required.
- Provide immediate Quality Support to existing QA / Production / Packaging line staff as and when required.
- Provide immediate Quality Support to additional Warehouse Facility.
- To undertake any ad hoc duties as required to sustain improvement and compliance of the Quality system
- Minimum of a degree (or equivalent) in a science related discipline. Minimum 2 years’ experience within a pharmaceutical company desirable but not essential. However, a combination of experience and / or education will be taken into consideration.
- Ability to handle multiple tasks in a fast paced environment with strong organisational and time management skills.
- Ability to work a varied schedule if required.
- Knowledge of GMP and Quality Management Systems.
- Excellent written, oral and interpersonal communication skills.
- Experience if working with various IT systems and software packages with strong working knowledge of MS office applications including word, PowerPoint and Excel.
For further information, and to apply for this Quality Assurance Technical Officer position or other engineering opportunities, please contact Adam Cromwell or visit our Website.
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Salary is usually negotiable, salary details listed are to be used as a guide and are based on factors such as your experience and expertise.
We reserve the right to heighten short listing criteria dependent upon the calibre of response.