This job is currently Archived,
Posted on : 16 April 2017
Location: Ireland Department: Quality/EHS Reports to: Quality & EHS Manager Principal Duties and Responsibilities: Support the Quality and Environmental, Health & Safety (QEHS) Management Systems and maintenance of certifications for DCC Vital sites, through activities such as: Coordination of audit schedules Auditing Risk assessments Creation/review of SOPs Change control Issues/Complaints/Recalls Facilitation of CAPA process Delivery of relevant training requirements as per annual QEHS training schedules Super-user for QMS software (Proquis) Support for Regulatory Devices support such as: Complaints/vigilance/recalls, Liaising with the HPRA/MHRA Completion of desk top audits Preparation and submission of data for monthly, quarterly and annual reports (KPIs) Support to requirements such as GDP, GMP, Tissues, Regulatory, Compliance Projects, as project lead and/or team member Provide cover for other team members as required Other activities as required by the role Relevant Third Level qualification Experience in GMP, GDP and ISO environments Experience of regulatory body liaison e.g. the HPRA, MHRA Flexibility to travel and ability to audit effectively in a multinational outage environment as the need arises-UK/IE (2 trips per month to other sites ) Desirable Qualifications: Working knowledge of ISO13485, ISO14001 and OHSAS 18001 Auditor Certified (e.g. ISO9001 and/or ISO13485 or pharma equivalent)- can train Knowledge of Irish H&S and Environmental Legislation and regulations desirable Manual Handling Certified, VDU Assessor- ideal not required QMS software systems experience Excel Desired Characteristics Pro-active Flexible and adaptable to changing environment Ability to interface effectively with all levels within the company as well as organizations outside Fannin (regulatory agencies) Proven problem solving and trouble shooting skills Strong oral and written communication skills Strong interpersonal and leadership skills Other Information: Please note that all DCC Vital staff work within a quality management system and that all of the above will apply to the full DCC Vital product portfolio which includes products such as medical devices, pharmaceuticals and tissues. Employee Signature _____________________ Date ________________________ - DCC Vital IS AN EQUAL OPPORTUNITY EMPLOYER - Although the above is a description of the requirements of your job, as stated in your contract of employment, you may be required to carry out other reasonable duties as the Company may require from time to time.
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