LSC have a great contract opportunity for a Quality Assurance Specialist to join a South Dublin based Biopharmaceutical company.
If you have 8 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you! About the Project - Key Responsibilities 1.
Operational Readiness, Validation & Documentation * Provide QA leadership duringdesign of new rooms, development of materials/people/waste flows and contamination controls (gowning, cleaning, desinfection)ensuring operational robustness.
QA review/approve associated risk assestments and SOP.
* Review and approve validation documentation including integrated line PQs, media fills, and environmental monitoring qualifications.
* Support QA review of MBR and recipe creation for filling, lyophilization, and associated aseptic operations.
2.
Technology Transfer & New Product Introduction (NPI) * Serve as the QA Lead for technology transfer and NPI activities, providing quality oversight throughout process validation and product lifecycle introduction.
* Review and approve technology transfer documentation including process descriptions, PPQ protocols, validation reports, and risk assessments.
3.
Quality Systems, Risk Management & Compliance * Lead and support deviation, CAPA, and change control management related to operational readiness, validation, and tech transfer activities.
* Conduct quality risk assessments for new processes, interventions, and aseptic operations.
* Ensure data integrity and right-first-time execution across all readiness and validation deliverables.
Education: * Bachelor's or Master's degree in Science, Engineering, Biotechnology, or related discipline.
Experience: * Minimum 8 years' experience in pharmaceutical or biotechnology manufacturing * Proven expertise in facility startup and Quality Oversight of Operational Readiness and and technology transfer knowledge of applicable regulatory requirements and experience with regulatory inspections including EU/FDA GMP, Annex 1, and process validation lifecycle requirements.
* Experience working in aseptic operations, relating to vial and syringe filling.
* Experience managing change control, deviations, and CAPAs through electronic QMS systems (e.g., Track Wise, Veeva Vault, PAS-X, SAP).
About you - Are your skills a match? 8 years working in Quality Assurance Strong technical understanding of Aseptic manufacturing and Validation Excellent collaboration, communication, and decision-making skills.
Analytical and pragmatic approach to quality risk management.
Ability to balance regulatory compliance with operational efficiency.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1 G/Stamp 4 visa to apply! Apply via this advert or contact Siobhan Cummins on if you have anymore questions about this role!