Job Description
I am delighted to be working with a Cork based pharmaceutical company who are well known in the industry for a great working environment, collaborative team and great staff retention. The business is currently undergoing sustained growth and are on the look out for an experienced Quality Auditor to join their team. This individual will need to have previous hands on auditing experience and ideally with external audits. This individual will join a highly experienced and technical team who are responsible for overseeing contract manufacturing organisations and service providers to ensure that the business' products are manufactured and distributed in compliance with internal procedures, FDA and other international regulations. KEY RESPONSIBILITIES Supplier & customer relationship management Perform quality audits of contract manufacturing facilities, including, but not limited to Rx, OTC, Dietary Supplement, Device and Sterile finished drug product manufacturing facilities to ensure compliance with cGMP and quality agreements Perform quality audits of third-party service providers to ensure compliance with regulatory and contractual requirements Perform responsible sourcing audits of contract manufacturing facilities as per company guidelines Assist in the development of audit programs including implementation of audit productivity tools Assist in the development and implementation of supplier quality risk management tools Interprets quality and regulatory issues and recommends solutions and best practices Negotiation, execution and maintenance of supplier quality agreements Generation and maintenance of supplier scorecards Operate within the Quality Management System across all SQ related activities Foster a culture of learning and engagement, empowering technical judgement and decision making REQUIREMENTS Educated to degree level or higher, minimum B.Sc. (biological or chemical sciences) or B. Eng, (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 and knowledge of cGMP, Quality Assurance and regulatory principles in a pharmaceutical manufacturing environment Solid understanding of basic pharmaceutical processes such as a solid dose manufacturing process, aseptic manufacturing processes, packaging process, etc. Experienced in risk management tools and techniques Demonstrated ability to lead suppliers to improve performance; including the ability to influence through effective communication and diplomacy Ability to work independently and make decisions based on judgement and integrity Proven analytical skills and ability to transfer findings into well written report formats Demonstrates and understands customs and beliefs of various groups or culture The business offers a hybrid working model with the ability to work from home up to 3 days per week (when not travelling). International travel up to 30% of the time to meet business needs. Please note that due to the nature of the role you will need to be able to travel without restriction. If you would like to find out more about this role please click the 'Apply Now' button below or reach out to Kellie on Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative. BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES. Skills: Quality auditing Supplier Auditing CMO Management Pharmaceutical manufacturing Risk assessments