Document Controller - 18-Month Contract - Dublin 15 - €45k
My client, a member of the Irish Pharmaceutical Healthcare Association, is seeking a Document Management Specialist to join their organisation, on an 18-month fixed term contract, based in Dublin 15.
This role is a full time, fully on-site position, with the possibility of a hybrid option after a short probation period (this is not fully remote).
As the Document Management Specialist, you will be responsible for supporting the use of document management and procedures in support of operations ensuring good record keeping and information retention.
Tasks & Duties
- Control and management of document lifecycles via EDMS application - Site Business Owner for EDMS application and QAdb (DM Web).
- Support effective resolution of document system queries or requests.
- Support smooth running of day-to-day tasks for document management workload (e.g., issuing QC worksheets, manufacturing batch records).
- Management of the Document Management Library & associated databases.
- Identify, implement and support OpEx activities within the DM function.
- Support Doc Mgt non-conformance investigation and CAPA activities.
- Scanning: Disaster Recovery for Quality and business critical documentation in line with global requirements.
- To provide support and training to staff in Document Management processes.
- Preparation of Monthly Report and budget oversight & auditing support.
- Support the management of Doc Management Service Providers (including completion of audits).
- Collaborate with cross-functional project teams or departments to support document control requirements for site wide project.
- Identify, implement and support OpEx activities within the Document Management function.
- Ensure compliance with relevant regulations and standards associated with cGMP including data integrity, ISO 14001, ISO45001, Health & Safety Legislation, Environmental Legislation, and also all site standards, policies, and procedures.
Knowledge, Experience & Qualifications
- Relevant work experience, preferably 7 years in Document Management environment.
- Demonstrate experience in routine Document Control practices with an understanding of compliance and data integrity.
- Experience in the use of EDMS type applications.
- Experience with scanning documents and database experience.
- Super User in Microsoft Office Suite: Word, Excel, Access, Outlook, Adobe Pro, and SharePoint.
- Excellent organisational skills with proactive and results oriented focus including high attention to detail.
- Experience in dealing with multidisciplinary teams, subcontractors and a wide customer base.
- Knowledge of OpEx tools an advantage.