Quality Assurance Analyst - Technical QA Syringe and Inspection Line, Dun Laoghaire, DublinOffice/Project Location: Dun Laoghaire, DublinEmployment Type: ContractWork Location: HybridPay: €45 - €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.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 Dun Laoghaire.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.Provide overall quality direction for processes and procedures associated with all aspects of new equipment introduction, including Computerised System ValidationAct 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 introductionLead 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 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.RequirementsUniversity 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 IntroductionProven 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 abilitiesIndependent, 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.PackageContract role - Hourly rate €45 - €57 per hourOnsite requirement is 3 days per weekContactKaren McHugh is the consultant managing this position.If you are a Quality Assurance Analyst interested in roles based in Dublin , you can contact Karen by e-mail at Karen@jobcontax.com Karen or phone 353 1 9696683 for a confidential chat.JobContax do not send CVs to clients without candidate permission.With over 50 years of technical recruitment experience, JobContax is the leading recruiter of Quality Assurance Analysts in Dublin and Ireland.Due to the large volume of applications, JobContax may not be able to respond to every individualstaglifeamgen
