Position Summary
We are seeking an experienced Senior Quality Assurance Professional to provide quality direction and oversight for activities related to the installation of new syringe and inspection lines and products at our facility in South Dublin. 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 Client policies.
Ensure all activities align with client safety standards, SOPs, and regulatory expectations.
Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations.
Preferred Qualifications
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)
Strong organizational skills with the ability to manage tasks through to completion.
Ability to work independently and remotely with minimum direct supervision.
Strong critical thinking and problem-solving abilities
Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.
Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
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