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- ...Validation (CSV) principles and GAMP 5 methodology Familiarity with GMP regulations and pharmaceutical manufacturing standards (FDA 21 CFR Part 11, EU Annex 11) Desirable Requirements Experience with MES platforms (e.g., Werum PAS-X, Rockwell PharmaSuite, or...SuggestedContract workFixed term contractWorldwideShift work
£48 per hour
...computerised systems validation , spreadsheet validation and laboratory equipment qualification. Solid working knowledge of GAMP 5 , 21 CFR Part 11 and related data integrity expectations, with practical application on site. Able to write, review and challenge validation...SuggestedLong term contractContract work- ...Collaborate with Automation, CSV, QA, and Operations teams during project execution. Ensure compliance with GMP, GAMP5, and FDA 21 CFR Part 11 requirements. Maintain documentation, SOPs, validation records, and infrastructure reports . Requirements Strong...Suggested
Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL)
Dunboyne, Co. Meathmore than 2 months ago - ...VBA macros) to increase efficiency while ensuring regulatory compliance, such as Good Automated Manufacturing Practice (GAMP), FDA 21 CFR Part 11, and EU Annex 11. Identify and implement continuous improvement opportunities, including leveraging Artificial Intelligence...SuggestedFull timeWorldwideFlexible hours
- ...computerised systems comply with applicable GMP, data integrity, electronic records and electronic signature requirements , including 21 CFR Part 11 and EU Annex 11 where applicable. Work closely with Engineering, Automation, IT, Quality, Operations, Laboratory and...SuggestedFull time
- ...rates. Maintain data integrity (ALCOA+) and validated state of serialization systems in line with GxP expectations, EU Annex 11 and 21 CFR Part 11. Quality, Compliance & Inspection Readiness Partner with Quality and Regulatory to maintain GDP compliance across the...SuggestedFull timeContract workHybrid workWork at officeLocal areaWorking Monday to Friday3 days week
€54.2k - €88.4k per annum
...Understanding of computerized system implementation, validation principles, data integrity requirements, and applicable regulations including 21 CFR Part 11, Annex 11, and GxP expectations. Familiarity with digital manufacturing systems and technologies, including MES, electronic...SuggestedWorldwide€54.2k - €88.4k per annum
...in site change controls, risk management and data integrity initiatives/programs You have expert knowledge of EU annex 11 and FDA 21 CFR Part 11 Thrive today. Grow tomorrow. #IRELIM #JOBSIEST #LI-Onsite #REGNIEQA #REGNQA Does this sound like you? Apply now to...SuggestedFull timeFor contractorsWorldwide€62.3k - €119k per annum
...reliability across the data platform Ensuring adherence to data governance policies and industry regulatory requirements including 21 CFR Part 11, GxP, and CSA; maintain comprehensive system documentation Leveraging GenAI and MCP/orchestration platforms to enhance team...SuggestedWorldwideWorking Monday to Friday- ...Quality focus. ~ Good working knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820). ~ Team Player with ability to develop strong working relationships. ~ Strong communication and inter-personal skills. ~...Suggested
- ...processes ~ Knowledge of IPC-A-610 and J-STD-001 ~ Experience with SCAR, 8D and CAPA ~ Working knowledge of ISO 13485 and FDA QMSR / 21 CFR 820 ~ Strong supplier management and technical problem-solving skills ~ Experience with SPC/statistics, Veeva QMS, ISO 13485 Lead...SuggestedTemporary work
- ...degree in engineering, Quality, or related field. At least 3 years of experience in a regulated industry. Knowledge of ISO 13485, 21 CFR Part 11, 21 CFR 820, Experience working on cross site or global system projects. Audit experience with FDA, BSI, or MDSAP....Suggested
- ...inspections. Manage complaint investigations, coordinate product recalls, and address quality defects. Ensure compliance with FDA CFR Parts 210/211/Q7, EU GMPs (ICH Q7, Volume 4), and AbbVie QA Policies. Review and approve Product Quality Reviews (PQRs) and track...SuggestedFull time
€63.2k - €103.2k per annum
...industry (e.g., FDA/cGMP), with demonstrated expertise in GMP regulations and compliance frameworks Strong working knowledge of 21 CFR Part 11, GAMP 5, validation/qualification methodologies, data integrity principles, and change control processes In-depth, hands-on...SuggestedFor contractorsWorldwide- ...DeltaV, PI Historians, MES, LIMS, ERP systems, OPC interfaces, and related manufacturing systems. Ensure compliance with GMP, FDA 21 CFR Part 11, EU Annex 11, GAMP5, data integrity, cybersecurity, and audit trail requirements. Support audits, regulatory inspections,...SuggestedFull timeContract work
- ...experience in CAPA, Quality Assurance, or Quality Engineering. Medical device industry experience preferred. Knowledge of FDA 21 CFR Part 820, GMP, and ISO 13485:2016. Key Skills Strong analytical, investigation, and problem-solving capabilities. Experience...Temporary work
€54k - €90k per annum
...function Profound knowledge and understanding of US, European and International Medical Device Regulations (ISO 13485, MDSAP, and CFR Part 820 Quality System Regulations desired) Ireland Pay Ranges: ~ Ireland : €54,000 - €90,000 EUR Annual At Stryker, we...Permanent employmentFull timeHybrid workLocal area
