Senior R&D QA Executive
Our client is a global innovator organisation with core competencies in the fields of pharma, biotech, medical devices and diagnostics to name but a few. Employing upwards of 30,000 people worldwide, this organisation sets trends in research-intensive areas with their products and services designed to benefit people and improve their quality of life. The Role: Our client currently requires a strong Senior R&D Quality Assurance Executive to join the Quality team on site in Galway. You will report to the Senior QA Manager and ensure that R&D operations, product transfers and quality processes are followed in a compliant manner. Key Responsibilities: Maintain efficient document management systems ensuring high quality of documentation within the R&D Department. Ensure R&D operations, laboratory activities, stability program and product transfers are conducted in compliance with global policies, procedures and applicable regulations. Conduct conformity assessment audits of R&D policies, procedures and quality systems to identify non-conformities and ensure prompt and effective correction actions are accomplished, ensuring the R&D department are in a state of continuous audit readiness. Function as Quality System SME for R&D related CAPA's, Deviations, Non-conformances, Vendor non-conformances and Change Control, responsible for prompt and efficient closeout. Monitor and report KPI Quality metrics of the R&D department for the site. Mentor, support and assist in the development of junior members of staff. Maintain a strong relationship with site manufacturing activities and support the approval of registration batches to support regulatory submissions. The Person: Minimum of a Bachelor's degree (or equivalent) in a Science related discipline and 6 years' relevant experience within a pharmaceutical/medical device company with a minimum of 4 years' experience within a QA role. Knowledge of working within an FDA/HPRA regulated facility. Knowledge of product development processes desirable. To learn more apply online or contact Orla Boyle at HRM directly on 353 91 782110 for a confidential chat. This job originally appeared on RecruitIreland.com.
114 days ago