Senior Quality Assurance Specialist
Remote
RK5297
Contract 12 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.



This role requires a strong understanding of Quality requirements associated with aseptic manufacturing, as well as an excellent understanding of C & Q / Validation and Technical Transfer requirements. The desired candidate should have a proven track record in QA leadership, and be comfortable working as part of a cross functional team.



Key Responsibilities:

• 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.
• Lead Quality review and approval of validation documentation associated with new facilities and new product introduction
• Lead QA review and approval of SAP BOMs, MBRs and recipes as applicable.
• Partner cross-functionally with PD, Engineering, and Operations teams to ensure all NPI activities are compliant with regulatory and Site Quality Requirements.
• Provide Quality Direction and input for Change Controls, CAPAs, and Deviation Investigations.
• Support Inspection Readiness and Regulatory Audits, representing QA for Validation and NPI areas.
• Conduct risk assessments and develop mitigation strategies for potential challenges in equipment / product 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 company policies.
• Ensure all activities align with company’s safety standards, SOPs, and regulatory expectations.
• Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations.

• University degree in a Science-related discipline.
• Minimum of 7 years’ relevant experience in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing)
• In-depth knowledge of applicable regulatory requirements and experience with regulatory inspections.
• Experience working in aseptic operations, relating to vial and syringe filling.
• Understanding of principles of Validation and New Product Introduction
• Proven experience in Quality Systems (change control, non-conformance, corrective and preventative actions)