Production Documentation Management Assistant

  • Cork
  • Cpl
Production Documentation Management AssistantKenny-Whelan & Associates are hiring a Production Documentation Management Assistant to join one of our Global Life Sciences Companies in Cork. Contact: Carmel Synnott on email : or call on Profile of the Role: The Production Documentation Management Assistant will assist in management of Production Batch Records, GMP Documentation and Electronic Systems associated with the Site Production Teams. Main duties and responsibilities:·Routing of new and revised procedures/, batch records and compliance documents in Regulus.·File documents in physical and digital records and ensure appropriate storage·Review and maintain the accuracy of the records, editing where necessary to ensure they are up to date·Management of Regulatory Documents, ensuring their accuracy, quality and integrity and compliance with version control·Upload documents in line with site SOP’s – appropriate templates used etc., ·Routing of new and revised procedures/, Batch Records and Compliance documents in Quality Doc Documentation Management System·Supporting Data Integrity- specifically the issuing, controlling and reconciling of procedural attachments.·Track documentation errors and highlight common problem areas.·Maintain confidentiality around sensitive documentation·Assist on internal and external auditsRequirements: ·Proven interest in working within production and understanding the Pharmaceutical Industry’s business processes.·Demonstrated excellent Documentation Practices and compliance with procedures.·Demonstrated high level of IT skills.·Strong interpersonal and communication skills with a willingness to help others.·Proven ability to deal with unexpected issues using a problem-solving skills.·Self-motivation with the ability to operate without close supervision.Education and Experience:Degree in Science, Engineering discipline or equivalentAdvance ECDL / Full MS Office Suite Regulus experience very desirableExperience of EDMS Please note: Monday to Friday and occasionally some non-scheduled call-in time to respond to operational needs.All applications will be treated with the strictest confidenceKenny-Whelan Contact: For further information please contact Carmel Synnott on 00 21 / or send your updated CV to