Auditor

Pe Global

Limerick

PE Global is currently recruiting for an Auditor for a client site in Limerick: Performs planned and unplanned Supplier or External Manufacturer (EM) audits to verify compliance to applicable government regulations, standards and to company policies and procedures. Provides supplier or EM compliance expertise to the organization as required. Essential Duties and Responsibilities (Other duties may be assigned): Assures that the supplier or EM quality system audit function complies with QSR/GMP, ISO and other regulatory requirements. Performs audits of suppliers or EMs 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 supplier or EM re audits of deficient matters and corrective actions, as needed and required. Assigns classifications and documents supplier or EM audit results in written audit reports that are distributed and reviewed by appropriate management. Monitors the effectiveness of supplier or EM 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 supplier or EM audits, re audits and corrective action responses. Provides direction and guidance to auditors in training and/or volunteer auditors. Collects and reviews supplier or EM audit metrics and communicates to site and worldwide management. Generates data for management reviews. Assists in formulating supplier or EM 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; and 7 or more years of related experience and/or training; or MS with 5 or more years; or Ph.D. with 3 or more years; or equivalent combination of education and experience. 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. Good written and oral English communication skills. Ability to read, analyze and interpret scientific and technical journals, financial reports, and legal documents. Knowledge understanding in FDA CFR Part 820, Part 610, Part 611, Part 11, and ISO 130485 regulations is required. Ability to select, manage and direct a team during an audit. Ability to respond to common inquiries, regulatory agencies, or members of the business community. Strong statistical skills and manufacturing process understanding. Ability to lead a team through a root cause analysis problem. Ability to effectively present information to top management, public groups, and/or boards of directors. Engages in constructive conflict. High tolerance for ambiguity in a complex environment. Makes the complex clear and easily understood by others. Ability to stand firm while being open to new approaches. Ability to build partnerships both internally and externally. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to use PC's and associated Microsoft software. Ability to effectively interface with governmental and independent auditors. Six Sigma, Lean, ISO lead auditor, or ASQ CQA certification and trainings are preferred. The position will require approximately 60% travel both domestically and internationally. Interested candidates should send their CV to Audrey.brennan@peglobal.net or call 0214297900. This job originally appeared on RecruitIreland.com.

2388 days ago