Get new jobs by email
- ...commissioning and validation Overseeing automation budgets, project timelines, and external vendor partnerships Ensuring compliance with 21 CFR Part 11 and GxP requirements Supporting internal and external regulatory audits Ensuring automation systems comply with...SuggestedFor contractorsLocal area
- ...and automation workflows. Configure and support middleware and integration platforms. Ensure all integrations comply with GxP, 21 CFR Part 11, and data integrity (ALCOA+) requirements. Participate in Computer System Validation (CSV/CSA) activities (IQ/OQ/PQ...Suggested
- ...platforms related to AI/GenAI. Proficiency in star schemas and data modeling tools. Knowledge of industry regulatory requirements (CFR Part 11, GxP, CSA). Stream processing experience (Kafka, Flink). Cloud certifications. In order to be considered for this...SuggestedLocal area
- ...update SOPs and training materials Authoring engineering documents, risk assessments (e.g., FMEA), and test plans per GAMP 5; enforce 21 CFR Part 11 and ALCOA+ data integrity (audit trails, electronic signatures, role‑based access) Providing site support, troubleshooting...SuggestedPermanent employmentFor contractorsLocal area
- ...flexibility and cross-functional expertise. This role may be for you if you have: A deep understanding of GxP regulations (e.g., FDA 21 CFR Part 11, EU Annex 11) and expertise in IT system validation and qualification processes. Proven ability to apply quality assurance...SuggestedPermanent employmentLocal area
- ...Regulatory & Standards Compliance ~ Ensure all relevant activities comply with applicable regulations and standards including: ~21 CFR 820 (Quality System Regulation) ~21 CFR 11 (Electronic Records & Signatures) ~ ISO 13485, ISO 14971 ~ IEC 62304 (Software...SuggestedFull timeContract work
Innovate Skillsource
Limerick17 days ago - ...Delegate and oversee QA work assignments to ensure compliance with statutory and regulatory requirements, including ISO 13485, FDA 21 CFR 210/211 cGMP, and IPEC Excipient standards Provide quality management oversight for existing products covering supply chain, production...SuggestedPermanent employment
- ...ability to influence decisions through technical insight. • Familiarity with medical?device regulatory frameworks (ISO 13485, MDR, FDA 21 CFR 820). Equal Opportunity Employer : We are proud to be an equal opportunity employer. We welcome and encourage applications from all...SuggestedPermanent employmentFor subcontractor
