Technical QA Specialist

3 days ago

Dublin, Ireland JobContax Full time

Technical QA Specialist, Dun Laoghaire, DublinOffice/Project Location:Dun Laoghaire, DublinEmployment Type: ContractWork Location:  Hybrid Onsite requirement is 3 days per weekPay: €50 - €57 per hourExperience: 7+ yearsVisa: EU passport or Stamp 4 visa requiredOur client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment. This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.Our client is expanding its manufacturing capabilities with a state-of-the-art Aseptic Manufacturing Facility, and are looking for a highly experienced Senior QA Specialist to join our team. This is a unique opportunity to play a key role in a high-impact project, providing Quality Oversight across Facility, Equipment, Utility, and Process Design, Installation, and Qualification. This role requires a strong focus on QA leadership in the design, installation, and qualification of facility, equipment, utility, and process systems, with particular emphasis on Validation Oversight.Provide QA leadership during facility design, and layoutProvide overall quality direction for processes and procedures associated with projectLead QA review and approval of URS, DS, QRAEs, and IQ/OQ/PQ protocols and reports.Act as the Quality point of contact and decision-maker during validation execution activities, ensuring all activities comply with regulatory and company standards.Ensure Computerised System Validation (CSV) meets regulatory and data integrity standards.Ensure validation documentation is robust, traceable, and inspection-ready.Drive risk assessments and mitigation strategies for new equipment and processes.Provide QA oversight for Change Controls, CAPAs, and Deviation Investigations.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.RequirementsUniversity degree in a Science or Engineering-related discipline.Minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry.Proven expertise in facility startup and Quality Oversight of Validation activities.Experience with change control, non-conformance resolution, and CAPA implementation.Excellent organizational, communication, and collaboration skills.Ability to work independently with minimal supervision and operate effectively across functional boundaries.Critical thinking and problem-solving abilities.Familiarity with Quality by Design (QbD).Proficiency in statistical analysis tools (e.g., Minitab, JMP) is a plus.Team-oriented mindset with the ability to thrive in a collaborative decision-making culture.PackageContract role - Hourly rate €50 - €57 per hourMinimum 24 month contractOnsite requirement is 3 days per week

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