Job Title: QA Specialist (12-Month Contract)
Location: Sligo, Ireland
Start Date: ASAP
Department: Quality Assurance
About the Role:
We are seeking a QA Specialist to support qualification, validation, and GMP readiness activities at our Sligo site. This role suits someone experienced in CQV, risk-based validation, and digital QA systems, looking to contribute to a high-impact cross-functional project.
Key Responsibilities:
* Provide QA oversight for CQV activities (e.g., fermenters, cleanrooms).
* Review validation protocols (VTPs, VQS, VTS) and perform risk assessments.
* Manage deviations, CAPAs, and change controls in line with global SOPs.
* Support GMP readiness, tech transfers, and batch documentation review.
* Assist with digital QA tools (e.g., Veeva Vault, TrackWise).
* Ensure compliance with 21 CFR Part 11, ALCOA+ standards.
* Participate in audits and qualification-related activities.
Requirements:
* Degree in Life Sciences, Engineering, or related field.
* 5+ years’ QA/Validation experience in biopharma or related industries.
* Strong knowledge of GMP, risk-based validation, and digital systems.
* Proficiency in deviations, CAPA, change control, and SOP review.
* Experience with systems like Veeva, PAS-X, SAP, or similar.
* Tech transfer/start-up project experience is a plus.
Contract Terms:
* Duration: 12 months (possible extension)
* Hours: 40 hrs/week
* Location: On-site in Sligo (some flexibility depending on project phase)
If interested send your CV to ssanchis@optimussearch.com
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