Site Internal Auditor

CPL

DUBLIN NORTH

Job Description. My Client is looking for a Site Internal Auditor that will assist with the implementation of the Site Internal Audit Program to align with start-up activities. The role shall support the launch of the Inspection Readiness Program ensuring the processes conform to policies and comply with cGMPs, Health Agency regulations and all other applicable governing regulation. Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. Position responsibilities as follows: Drive implementation of the Site Internal Audit Program to align with start-up activities and approved schedule. Support the launch of the Inspection Readiness Program. Co-ordination and implementation of the Site GMP readiness Plan aligned with site start-up milestones. Lead and perform internal audits (facility, system and walkthrough) in addition to management of the internal audit schedule at the site. In-depth knowledge of US and European cGMP guidelines, ICH and other international regulatory requirements, as applicable to the site. Responsible for ensuring that there is an effective Quality Management System (QMS) is in place, with emphasis on continuous improvement of the QMS. 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. Ensure that quality issues are identified, addressed and resolved before activities commences. Be an advocate of continuous improvement in the Quality Management Systems. Initiate and maintain Quality related metrics related to the Site Internal Audit & Inspection Readiness programs, ensuring effective communication and follow up of same. Represent the sites Quality Management System during Board of Health and other GMP inspections. Maintain current technical, compliance, regulatory, and audit skill knowledge to ensure audit program effectiveness through identification of early compliance warning signals. Effectively communicate audit/inspection results to stakeholders and site leaders. Evaluate root cause analysis, CAPA responses, monitor CAPA completion, and verify CAPA effectiveness for audits & inspections for complete remediation. Support the preparation and hosting Health Authority inspections and Divisional GMP Audits. Generate and report metrics / trends for program adherence to requirements and effectiveness. Qualifications and Experience. General. This role requires a seasoned QA Professional with circa 10 years’ experience in the Pharmaceutical or Biological industry. A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends. Technical. Must have at least 2 years experience in delivering Site Internal Audit and Inspection Readiness programs in a regulated environment. People. The motivation to be an inspiring member of a high performing team. Communication, decision making, people influencing and project management skills will be important. Strong contemporary knowledge of relevant cGMPs and Quality System regulations as they pertain to the site and current industry trends. GMP Audit and Inspection Readiness experience in the Pharmaceutical industry. Problem-solving / critical thinking – ability to understand connections between different technical/quality system areas and recognize potential compliance issues. The desire to continuously learn, improve and develop. Critical to success will be an expert level of knowledge of cGMP. Education. Bachelor’s degree in Chemistry, Biology, Microbiology, Engineering or in a relevant discipline, the successful candidate will also ideally have a proven track record in delivering excellence.

1553 days ago