Senior Compliance Specialist
Lotusworks
Limerick
About Us. A valued and trusted partner to the world’s leading companies. We are committed to service excellence through our talented people who are empowered to be innovative and best in class. Location. Limerick is the capital of Ireland’s Mid-West region and is noted for its shopping, its dining and entertainment, its historical significance. Limerick has something to offer everybody thanks to its many cultural, historical, architectural, sporting, shopping and business activities. Join us and work with us to deliver the excellent service we are renowned for with our clients. Be part of something great. Your Job Purpose. Working with the LotusWorks team as a Senior Compliance Specialist, you will perform planned and unplanned client audits to verify compliance to applicable government regulations, standards and to company policies and procedures. Responsibilities. Assures that the client quality system audit function complies with QSR/GMP, ISO and other regulatory requirements. Performs audits of clients for compliance to applicable government regulations, material specifications, to international standards and to company policies and procedures. Ensures audit reports are issued within the prescribed time frame. Performs clients re audits of deficient matters and corrective actions, as needed and required. Assigns classifications and documents clients audit results in written audit reports that are distributed and reviewed by appropriate management. Monitors the effectiveness of client’s corrective action responses. Can serve as lead auditor, leading a team of auditors, technical experts, auditors-in-training and/or volunteer auditors. Maintains files containing reports of client’s audits, re audits and corrective action responses. Provides direction and guidance to auditors in training and/or volunteer auditors. Collects and reviews clients audit metrics and communicates to site and worldwide management. Generates data for management reviews. Assists in formulating client’s procedures to be followed by the auditing group. Maintains abreast of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings. Responsible for following all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition. Requirements. BS in a related science or engineering field of study. Pharma experience is a necessity. 7+ years’ experience working in a similar environment. Proven ability to conduct and manage audits required. Computer Systems Validation experience preferred. Knowledge dealing with the Food & Drug Administration. Knowledge and skills in quality-related methods and techniques including auditing principles and techniques, quality terminology, quality management principles and their applications and quality management tools and their applications. Benefits. Life Assurance. Pension Contribution. Training & Educational Assistance (Engineers Ireland CPD Members. Healthcare Contribution. Annual GP Check-Up. Extra Annual Leave. Healthcare Screening. Not ready to apply, or have some questions? Call our Talent Specialist’s on +3537191-69783 or Email jobs@lotusworks.com and we will be happy to help! LotusWorks is proud to be listed in the Best workplaces 2017. Empowering talent we care about for over 27 years. LotusWorks is an Equal Opportunity Employer. This job originally appeared on RecruitIreland.com.
2382 days ago