- Reference: GY43107AO
- Job Type: Permanent
- Location: Galway, Limerick, Limerick city
- Category: Science, Pharmaceutical & Food
Essential Duties and Responsibilities include, but are not limited to, the following:
• Manage and continually improve Quality Risk Management (QRM) system supporting groups identified in the summary.
o Formulate risk management strategies, principles, methods and tools, and document in appropriate policies, procedures, and reports.
o 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.
o Manage and lead data driven risk assessments (risk identification, analysis and ranking).
o Responsible for developing and managing data analysis and statistical tools used to support quality risk management activities.
o Oversee QRM program to ensure risk assessments are conducted as required frequencies and manage the overall process, tasks, and communications
o Communicate the outcome from quality risk management activities to all business partners
o Work with the management team to integrate quality risk management concepts and philosophies into the overall Quality System.
o 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
o Represent an 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.