Assoc MGR Quality Risk Management

Harmonics Recruitment

Limerick

General Responsibilities: Manage and continually improve Quality Risk Management (QRM) system supporting groups identified in the summary. Formulate risk management strategies, principles, methods and tools, and document in appropriate policies, procedures, and reports. Educate and train staff (cross sites) in quality risk management principles and practices and act as a subject matter expert and resource for QRM matters. Manage and lead data driven risk assessments (risk identification, analysis and ranking. Responsible to develop and manage data analysis and statistical tools used to support quality risk management activities. Oversee QRM program to ensure risk assessments are conducted as required frequencies and manage the overall process, tasks, and communications. Communicate the outcome from quality risk management activities to all business partners. Work with the management team to integrate quality risk management concepts and philosophies into the overall Quality System. Function as a fully integrated member of the Quality Assurance management team, advising on all QRM matters within the IOPS organisation, as well as being the primary interface with customers. Represent the company’s approach to Quality Risk Management during regulatory inspections and partner audits. Education and Experience: Requires a 3rd Level Qualification in Life Sciences with 6+ years of relevant progressive experience in QA within the Pharma / Biopharma industry. Experience in the pharmaceutical/medical device/biotechnology industry with proven experience in leading cross functional teams preferred. This job originally appeared on RecruitIreland.com.

2762 days ago