The Document Controller will be primarily responsible for the control, review, release and obsolescence of documentation for Company site(s), including procedures and specifications. Will also be responsible for day to day administrative tasks.
Will work within the Quality Systems team, under general supervision, with responsibility to ensure an effective and efficient management and release of documentation, this includes, but is not limited to the following duties:
• Responsible for all activities related to document routing, distribution and release to assure that the latest effective copies are available as required.
• Ensure prompt archiving and storage of all Company documentation.
• Timely retrieval of documents and information, as needed to complete investigations and/or reports.
• Support & comply with GMP/QSR, ISO 13485 & CE-mark requirements.
• Input to & maintain quality KPIs for trending/management reviews.
• Assist in issue investigations, provides input to correction & resolution, rework, problem solving, and process improvements.
• Maintain an organized & clean work environment.
• Third Level Qualification (Diploma in Business Studies or Administration, or equivalent 2 year certification) preferred.
• Relevant experience in a similar administrative type role in a Regulated Industry, advantageous.
• High level of PC skills required, must be highly proficient with Microsoft.
• Have an understanding of archiving systems and methodology and electronic document managing systems.
• Have an understanding of the following standards ISO 13485 and ISO 9000 and CFR Part 820 Quality System Regulations
• Must be highly organized and disciplined and be able to demonstrate their ability to meet deadlines with acute attention to detail
• Is a self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
• Be capable of working as part of a multi-disciplined team.