Quality Document Associate

OVERALL ROLE OBJECTIVE: To work as part of a Document Control team responsible for compilation, issuance and review of GxP 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.

JOB SPECIFIC RESPONSIBILITIES: The post holder will: 1. Control GxP documentation (Master Batch Records, logbooks, SOPs, specifications, validation documentation etc) in accordance with Almac Pharma Services internal procedures. 2. Issue batch records in accordance with the Batch Tracker and to support the Operations schedule as required. 3. Responsible for assigning/verification of batch variable data on TROPOS as per the internal variable data management process. 4. Issue and retrieve GMP documentation to / from departments as assigned. 5. Circulate quality system related documentation (change requests, suspect analytical results, complaints etc) to all relevant departments. 6. Manage and distribute controlled documents, maintaining current effective versions in hard copy and electronically. 7. Ensure all designated Document Control storage/ archive areas are tidy, presentable and organised in a logical way. 8. Archive, retrieve, destroy and track GMP associated documentation in accordance with Almac Pharma Services procedures. 9. Collate and review data for QA reports and investigations. 10. Maintain all quality system indexes and electronic tracking systems e.g. WOLF, LiveLink, TrackWise. 11. Support the business as required to prepare for both Client and Regulatory Audits. 12. Any other additional duties deemed necessary by a senior team member QUALIFICATIONS

Minimum Leaving Certificate (or equivalent) at Grade C or above in English Language and Maths EXPERIENCE

Previous administrative experience working with control or management of documentation. Must have significant experience working with Excel. KEY SKILLS

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