Senior Quality Assurance Specialist RK3854 18 Months Dublin
We're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin.
This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties:Provide overall quality direction for processes and procedures associated with all aspects of new equipment introduction, including Computerised System Validation.Act as the Quality point of contact and decision-maker for C & Q / Validation execution activities, ensuring all activities comply with regulatory and company standards.Quality review and approval of validation documentation, including:Design Specifications (DS), User Requirements Specifications (URS), and Quality Risk Assessments (QRAES).Validation Plans, Protocols (IQ, OQ, PQ), and associated reports.Ensure robust and compliant validation documentation to support site activities.Conduct risk assessments and develop mitigation strategies for potential challenges in equipment introduction.Provide input and quality oversight for change control development and implementation.Ensure timely and robust implementation of change controls and CAPA records.Write, review, and approve Standard Operating Procedures (SOPs) in alignment with policies.Ensure all activities align with safety standards, SOPs, and regulatory expectations.Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations.Education and Experience:University degree in a Science or Engineering-related discipline.Minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry.Proven expertise in new equipment introduction, technical transfer, PPQ execution, and lifecycle management.Strong understanding of validation principles and regulatory requirements for C & Q / Validation (FDA, EMA guidelines).Experience with change control, non-conformance resolution, and CAPA implementation.If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
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