Compliance & Audit Specialist

Careerwise Recruitment

Limerick

COMPLIANCE & AUDIT SPECIALIST required by CareerWise Recruitment for our manufacturing client with the option of being based in either Limerick or Cork. Initial 9 month contract on offer. The COMPLIANCE & AUDIT SPECIALIST will perform planned and unplanned Supplier or External Manufacturer (EM) audits to verify compliance to applicable government regulations, standards and to company policies and procedures. THE ROLE: * 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. 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. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin. Supporting Business Demands & Growth since 1999. CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times. This job originally appeared on RecruitIreland.com.

2374 days ago