QA Compliance Auditor
Harry Walsh Associates Ltd
Dublin North
Our client, a Global Pharmaceutical company, is expanding their global QA Audit & Compliance team. In this role, you will perform evaluations for compliance with US and foreign regulation requirements (minimally may include the Americas, Asia, Africa, Australia, European Middle East regions) and provide constructive evaluation of quality related systems for suppliers that provide materials, services and products to client. Suppliers can include API suppliers, contract labs, excipient suppliers, commodity suppliers, devices, specialty pharmacies, logistic providers and third party manufacturers. Their execution in the area of GMP compliance and quality assures that activities are performed and documented in accordance with company policies/procedures and applicable quality and regulatory requirements intended to assure the quality, effectiveness and safety of our products. Experience: Bachelor’s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering. Must have a technical background and requires understanding of the audit process and knowledge of worldwide requirements related to GMP regulations for quality systems and compliance. 2+ years in Quality Assurance with some project management experience in the pharmaceutical, medical device/nutritional or related industry. One year in compliance/auditing is required. Total combined experience expected to be at least 6 years. Must understand a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, support and service and understand the principles of quality management. The individual must have excellent oral/written communications skills. Personal skills needed include interpersonal skills, tact, open mindedness, maturity, tenacity, self-reliance, organizational/administrative skills and sound judgment. Effective communication skills are essential with an ability to work effectively outside of the company and across functional and technical areas. ASQ certification desired, not required. 40% International travel. This job originally appeared on RecruitIreland.com.
2389 days ago