Quality Document Administrator
Our client in Dundalk require an experienced Quality Document Administrator
Location - Dundalk
Hours of Work - Flex 40
Rate of Pay - €11.60p/h
To work as part of a Quality Document Administration team responsible for compilation, issuance and review of GMP documentation. The post holder will assist in the maintenance of the Almac Pharma Services Quality system and will participate in investigations and trending of quality performance indicators as appropriate.
The post holder will:
- Generate GMP documentation (Master Manufacturing and Packaging Specifications, SOP's, specifications, validation documentation etc) in the approved formats.
- Issue batch records in accordance with the Production schedule as outlined in Almac Pharma Services internal procedures.
- Issue and retrieve GMP documentation to / from departments as assigned.
- Circulate quality system related documentation (change requests, deviations, CAPA, suspect analytical results, complaints etc) to all relevant departments.
- Manage and distribute controlled documents, maintaining current effective versions in hard copy and electronically.
- Ensure that all designated Document Control storage/ archive areas are tidy, presentable and organised in a logical way.
- Archive, retrieve and track GMP associated documentation.
- Collate and review data for QA reports and investigations.
- Maintain all quality system indexes and electronic tracking systems e.g. WOLF.
- Junior Certificate (or equivalent) at Grade C or above in English Language and Maths.
- Previous experience within a Quality System or Manufacturing environment
- Proven ability to work effectively on own initiative as well as effectively contributing to the team environment.
- Effective communication skills (both written and verbal)
- Proficiency in use of IT applications (Word, Excel, Outlook etc)
- Excellent attention to detail
- Proven ability to plan and prioritise workload