Location: 34501 - EMS FERMOY IRE - Fermoy, CO IE (Primary)
OBJECTIVES OF POSITION: The administration/control of documents in order to ensure that the Company maintains compliance with internal standards, external standards, operating procedures and requirements.
RESPONSIBILITIES: Administers Company change control procedures to assure that changes to all official documents comply with regulatory requirements and are approved prior to use - Usage of Agile.The development and maintenance of effective documentation systems and procedures. Maintaining master documentation (softcopy & hardcopy) such as Standard Operating Procedures, Protocols & Validations, Forms, Labels, etc.Assure the availability of the current revision documents for use within the plant.Ensure that quality records are filed/stored and retrieved in accordance with record retention policy/procedures.Maintain various indexes and logs (e.g., Document Control Log) and update as required.Trains other Company employees in the document control and change control systems as required.Assist if and when necessary in the preparation for and during external audits.Generation, management and distribution of reports as required.Plays an active role on quality teams within the organization and works with cross functional groups to identify and implement documentation changes and improvements.Ensures compliance with all Company policies and procedures, including safety rules and regulations.Other duties as assigned by manager/supervisor.Quality: Assure ongoing compliance with quality and industry regulatory requirements.Health & Safety: Ensure compliance with Health & Safety Legislation and Regulations.MEASUREMENTS: Performance will be evaluated with reference to the predetermined standards of performance as agreed upon with the position's supervisor. Predominantly the appraisal shall relate to the overall performance of Documentation Control Area and Documentation Control Practices.PERSONNEL SPECIFICATIONS ESSENTIAL: 1-2 years Document Control or other related experience.Familiarity with ISO and FDA Quality Systems Regulations and international quality system standards.Proficiency in the use of personal computers and computer database software, including Microsoft Office Suite applications (Google, Excel, Word and PowerPoint).Employs problem-solving skills to identify alternative solutions, project consequences of proposed actions, and implement recommendations in support of goals to resolve documentation system related issues.Works effectively in a Team environment.Excellent written and verbal communication skills. Proficient in English usage, spelling, grammar and punctuation. Ability to effectively present information to top management.Exceptional organizational skills. Capable of managing multiple jobs and prioritizing projects based on needs of the business.Self-motivated and self-directed. Requires minimal guidance once clear goals and responsibilities are established.Produces quality work in a reasonable timeframe.DESIRABLE: Medical Device Industry Experience.Experience with company-wide Change Management System (Agile).Ability to prioritize and manage the workload as required.Ability to work on own initiative and a high level of attention to detail.Ability to define problems, collect data, establish facts, and draw valid conclusions.
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