Stability Specialist - Pfizer Pharmaceuticals
Grange Castle, Dublin West
Department: Quality Assurance
The role will be to provide for the appropriate management and technical expertise in order to support and maintain the stability programs conducted by the QA Stability group and designed to support new and existing product licensing requirements. The role requires a close working relationship with Quality Control, Manufacturing, Regulatory Affairs and Development groups.
• Provide technical expertise in the design, implementation and management of stability studies, including relevant documentation, in line with current regulations, PQS and business needs. All related procedures and documentation to be maintained accordingly.
• Facilitate the creation and maintenance of the schedule for completion of the Annual Stability Program.
• Key role in any atypical or out of specification investigation.
• Facilitation and technical support for Stability Review Board (SRB) process.
• Authorship, review & approval of stability sections of regulatory filings.
• Support the introduction of new products.
• Trend reviews and SQRT (Site Quality Review Team) updates where required
• Safety and housekeeping considerations
• Execute responsibilities in line with Right First Time principles
• Ensure resolution of and/or appropriate escalation of issues
• Demonstrating company values and Pfizer competencies
• Ensure that all department metrics are adhered to and reported on time.
• Provide subject matter expertise and support for systems, technologies and products.
• Identify Continuous Improvement opportunities and progress Continuous Improvement projects.
• Participate in decision making in consultation with relevant stakeholders
• Ensure strict adherence to site policies/procedures, cGMP and environmental, health and safety regulations.
• Area/departmental weekly/monthly reporting.
• Third level qualification or an equivalent combination of education and experience to operate at this level.
• 3+ years working in a QC environment, ideally with some experience of Stability testing.
• Strong technical writing skills.
• LIMS experience
• Basic knowledge of statistical methods and Minitab software
• Working knowledge of ICH Stability guidelines
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organisation.