Arcadis are a seeking a Quality Documentation Specialist for a Pharmaceutical assignment located in Ringaskiddy, Cork. This is initially a 12 month contract to support the Document Control Team on site. Hybrid working available (3x days WFH and 2x Days onsite)
The successful Documentation Specialist will be responsible for carrying out tasks and projects related to document control by Good Manufacturing Practice (GMP). These activities include administration of the Electronic Document Management System (EDMS), preparation/submission of documents into and retrieval from archive, and the management of controlled documents through the review, approval, circulation, and revision processes.
Responsibilities
Provides support and direction to all departments in respect of Document Control to ensure business, quality and compliance goals are met. Partners with other Departments to ensure that Documentation programs and Records Management policies are completed in a compliant and efficient manner.
Supports the development and management of GMP compliance systems through the following activities: Carries out tasks related to the management of Document Control and Records Management in respect GMP regulated documents and records
Reviews received documents for conformance to site systems in respect of EDMS and GDP requirements.
Liaises with document owners in respect of approval schedules and implementation of new or revised documents.
Provides feedback from document review to the document owners.
Coordinates review and approval routings for SOPs and other GMP regulated documents.
Tracks documents through the review and approval processes and advises relevant personnel accordingly.
Generates reports and metrics from the system.
Prepares and catalogues documents for archival.
Manages document retrieval from archive storage as requested.
Regulates access to on-site document storage.
Audits internal and external document storage/archive systems.
Requirements
A minimum of 3 years’ experience in a document management or related role within the biological and/or pharmaceutical or medical device industry.
Knowledgeable of FDA/HPRA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals/Medical Device.
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