€74.77k per annum
...interpersonal, communication and team leader/member skills at all levels of the organisation.
Working knowledge of Quality Systems (FDA/ISO) within a regulated environment, and ERP/ASCP (SAP preferred)
High understanding of Supply Chain Finance.
Good Manufacturing Processes...
ECS Resource Group Ltd
Athlone, Co. Westmeath
5 days ago
...findings
Communicate audit findings by preparing a final report discussing findings with audditees
Compliy with legal/licensing./ISO requirements, enforcing adherence to requirements, advising management on needed actions
Perpare special audit and control reports by...
.../ technical knowledge.
Developing and implementing solutions to sustain and improve the QMS.
Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
Participate in the site change control, ensuring that all changes to validated processes are...
...Quality Systems requirements for medical devices and medicinal product (e.g. MDD, EU GMP Guidelines Vol IV Part 1 for medicinal product, ISO 13485). You will commit to working within the ethos of the Company Mission, Medical Devices & Supplies Guide to Compliance and Quality...
...technical and problem-solving skills
3.Excellent attention to detail displaying exceptional GDP and GMP.
4.Working knowledge of relevant ISO standards and guidance documents
5.Proficient in use of MS Office with ability to complete data analysis using Microsoft excel...
...for the organization, documentation and maintenance of the quality system to be compliant with, as appropriate, the following standards: ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards . This role...
...facility maintenance activities where practical to maintain a safe working environment.
Quality Compliance: Ensure compliance with ISO 9001 Quality Management System requirements, adhering to process documents and procedures.
Requirements:
Electronics Qualification...
...quality inspection instruments are accurate and regularly calibrated, tested and audited.
Assist with ensuring that the Company retains ISO accreditation.
Conduct internal audits and external audits as required.
Host audits of the Company’s operations by external...
...improvements to the quality system that ensures its suitability, adequacy, and effectiveness.
Understand and ensure compliance with cGMP, ISO 13485, and FDA 21 CFR Part 820 regulations.
Work closely with commercial and operations to build value with top 10 key accounts and...
...at Audit standard at all times, this includes but is not limited to all notified bodies associated with the Tullamore plant, e.g. FDA, ISO, TUV, IMB, ENHESA, NSAI and IDA.
Ensure site production trainers fully trained and competent.
Developing best practices to reduce...