|Sector||:||Manufacturing & Production
IT / Software
Engineering & Technical
Role of this position
* Assist in the day to day activities of documentation control.
* Maintain a Documentation department that meets regulatory, corporate, facility standards and delivers documentation to customer expectations.
* Maintain accurate control and distribution on all approved and regulated facility required documents, standards and software, both within the Document Control area.
* Work with internal customers and suppliers to ensure documentation control meets their requirements.
* Conduct scheduled controlled document reviews.
* Provide training to personnel on use of Electronic Document Control System.
* Administer Records Retention system for allocated records to satisfy site needs. Prepare, scan, verify and index documents according to written procedures. Co-ordinate document archiving with affected Departments and effectively index for traceability. Co-ordinate requests for document filing/retrieval with external document storage provider utilizing the systems/SOPs provided.
* Other ad-hoc duties as assigned by the Quality Systems Manager.
* Ensure continual Quality System compliance by adherence to established and evolving Company QS requirements
* Assist in the Control and maintenance of Validation documents.
* Maintains database for all storage of documents.
* Retrieve all of documents as required in a timely manner.
* Provide direction and guidance to personnel that use the engineering change process and document control process.
* Administer the Engineering Change Order, Quality System Change Order process and ensure effective operation according to procedural requirements. This includes; controlled number assignment; reviewing submitted engineering change packages; Coordinating approvals; Implementation of ECO through Document Control and MRP system;
* Downloading, control and issuance of medical device software for use in Manfacturing areas
* Assist in training of new users in SMART DOC.
* Qualification in Quality, Science, Business or Engineering, and/or 3-5 years experience in a similar role.
* Must have excellent computer skills, including Microsoft Office, Excel, Document Control Packages, MRP etc.
* Detail orientated and organised with a good multitasking ability.
* An ability to learn Quality System requirements and an ability to ensure adherence in FDA Documentation Control.
Please call Tom Devaney today for further information on 091-758771 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Medical Devices, Pharmaceuticals, Life Sciences, ICT, Engineering, Food and Agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.