Job Description
Our client, a healthcare manufacturing company based in Galway, now require a Documentation Specialist to own and manage department mailboxes such as Documentation Services mailbox.
The successful candidate will own department, maintains and implement Product Lifecycle Management system in support of quality systems and practices to meet company, customer and regulatory requirements. Support the management of licences (e.g. updating mail listing).
This role serves as a quality representative contact on own area of expertise in supporting the manufacturing facility.
Responsibilities of Documentation Specialist:
Provide support to own department and site as required, including Audit support, troubleshooting CN / licence issues.
Involved in metrics planning and reporting.
Represents the documentation department and Product Lifecycle Management as needed; Service as liaison for national and international documentation.
Detailed understanding of procedures used within the Documentation Services Group and basic understanding of ISO13485 and CFR/GMP requirements.
Demonstrates basic knowledge of medical device manufacturing process controls and quality system, including audit and CAPA.
Facilitate and roll-out training to new and existing Product Lifecycle Management users both in Galway and in other sites, as required.
Serve as a liaison between the Global Systems & Process Team and users at a site (e.g. troubleshooting, project/document type creation, etc.).
Requirements for Documentation Specialist
Third Level qualification in a relevant discipline (HETAC Level 7).
3+ years' experience in a Quality / Documentation role, coupled with knowledge of the ISO13485 regulatory requirements.
Good understanding of quality systems and change management.
Proficient in Microsoft Word & Excel.
Good understanding of Product Data Management systems. Detailed knowledge of PLM and SAP would be an advantage.
Strong team member with the ability to identify and drive quality improvements.
Demonstrate excellent communication and interpersonal skills.
Please contact Larry on 01-2302400 / larry@rftgroup.ie / www.rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
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Key words; Documentation, Quality Assurance, Investigations, Product Lifecycle management, Product Development, Product Validation, Registration, GMP, FDA, Clare, Galway, Roscommon, Mayo, Connaught.