Job Description
**Quality Auditor for Pharmaceutical Company** A Cork-based pharmaceutical company seeks an experienced Quality Auditor to oversee contract manufacturing organisations and service providers, ensuring compliance with internal procedures, FDA, and international regulations. **Job Description** We are looking for a highly skilled Quality Auditor to join our team. The ideal candidate will have previous hands-on auditing experience, ideally with external audits. The successful candidate will be responsible for: * Supplier & customer relationship management * Performing quality audits of contract manufacturing facilities and third-party service providers * Assisting in the development of audit programs and quality risk management tools * Interpreting quality and regulatory issues and recommending solutions * Negotiating and maintaining supplier quality agreements * Operating within the Quality Management System **Requirements** * Educated to degree level or higher (B.Sc. in biological or chemical sciences or B.Eng. in process and chemical) * 5+ years QA pharmaceutical manufacturing experience in a regulated facility * Broad knowledge of at least one manufacturing dosage form * Pharmaceutical auditing experience preferred * Solid understanding of cGMP, Quality Assurance, and regulatory principles * Experienced in risk management tools and techniques **Company Overview** Our company is a Cork-based pharmaceutical company known for its great working environment, collaborative team, and great staff retention. We are currently undergoing sustained growth and are looking for an experienced Quality Auditor to join our team. **Key Responsibilities** * Perform quality audits of contract manufacturing facilities and third-party service providers * Assist in the development of audit programs and quality risk management tools * Interpret quality and regulatory issues and recommend solutions * Negotiate and maintain supplier quality agreements * Operate within the Quality Management System **Benefits** * Hybrid working model with the ability to work from home up to 3 days per week * International travel up to 30% of the time * Opportunity to work with a highly experienced and technical team