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 activities.In-depth 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., TrackWise, 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 1G/Stamp 4 visa to apply!
Apply via this advert or contact Siobhan Cummins on 021 4777329 if you have anymore questions about this role!
