QA Lead Auditor

MSD

Carlow

Key responsibilities: Responsible for ensuring that the process for the manufacture of vaccines and biologics are in compliance with cGMP and the associated regulatory requirements. Responsible for ensuring that there is an effective Quality Management System is in place. Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety and reliable supply to our customers. Drive compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements.  Lead proactive evaluation of site compliance against emerging regulatory trends.  Actively participate and in Site/Quality committees and works with other site functional groups, such as the EC Laboratory, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives.  Partner with colleagues cross functionally to provide support and advice on day to day basis ; thereby ensuring department is audit/inspection ready. Ensure that quality issues are identified, addressed and resolved before activities commences. Responsible for leading Board of Health and other GMP inspections. Be an advocate of continuous improvement in the Quality Management Systems. Initiate and maintain Quality related metrics, ensuring effective communication and follow up of same. What you’ll need: Experience leading Board of health inspections. In-depth knowledge of US and European GMP guidelines, ICH and other international regulatory requirements, as applicable to the site. Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements. Assist in the proactive evaluation of site compliance against emerging regulatory trends. Minimum of 12 years' experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in quality and/or manufacturing roles, which includes leadership roles with experience in a front-line supervisory role in operations environment. Advanced leadership skills including ability to lead across function team and work across boundaries.  Communication, decision making, people influencing and project management skills will be important.  Critical to success will be an expert level of knowledge of cGMP and Quality System regulations as they pertain to all aspects of the Carlow site.  As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process. We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world. Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model. So, if you are ready to: Invent solutions to meet unmet healthcare needs, please apply today.  .

669 days ago