Quality Document Administrator

OVERALL ROLE OBJECTIVE 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. JOB SPECIFIC RESPONSIBILITIES 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 and 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 and archive areas are tidy, presentable, and organised in a logical way. Archive, retrieve and track GMP associated documentation. Collate and review data for Quality Assurance reports and investigations. Maintain all quality system indexes and electronic tracking systems such as WOLF. This role requires coverage beyond normal working hours on a regular basis and it is a condition of your employment that you are able to fulfil this requirement of the role. QUALIFICATIONS 3 A Levels or equivalent at Grade C or above EXPERIENCE Previous experience within a quality system or manufacturing environment 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 information technology applications such as Word, Excel and Outlook Excellent attention to detail Proven ability to plan and prioritise workload