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ClinigenSantryworkable.com
audits, and HPRA inspections.
• Follow and enforce all SOPs, Job Aids, and Quality procedures.
Outbound Operations
• Oversee daily pick, pack, and dispatch activities, ensuring turnaround times and accuracy targets are met.
• Allocate workload...
PHIBRO ANIMAL HEALTH CORPIreland
lead internal and external audits.
• Drive compliance to regulatory standards & be audit facing to bodies such as the HPRA.
• Foster a culture of accountability, innovation, & technical excellence across the engineering function.
• Ad hoc duties...
1 similar jobs: Dublin
Dublincv-library.ie
RP) on a Wholesale Distribution Authorisation, ensuring compliance with EU GDP (2013/C 343/01) and HPRA requirements.
• Managing and maintaining the GDP Quality Management System (QMS), including deviations, CAPAs, change control, risk management...
Complete Laboratory SolutionsGalway
About CLS
Complete Laboratory Solutions (CLS) is Ireland's highest-accredited contract laboratory, licensed by both the HPRA and the FDA. An Irish-led multinational, CLS provides trusted expertise and solutions to clients across diverse sectors...
Westportcv-library.ie
on multiple implementation projects.
Be familiar with MES application and configuration rules and requirements including interfacing (preferably POMSnet).
Experience of batch processing operations in an FDA/HPRA regulated industry. Strong knowledge of cGMP...
UPSDublin
A full-time, permanent, on-site role at UPS Healthcare, Harristown, Dublin (Monday to Friday) Your tasks Lead the healthcare quality programme for UPS Healthcare in Dublin and act as the certified Responsible Person (RP) Ensure full compliance with HPRA, GDP...
PHIBRO ANIMAL HEALTH CORPSligoappcast.io
of active substances used in the manufacture of veterinary medicinal products complies with the requirements of Veterinary Medicinal Directive 2019/6.
• Support preparation for supervising competent authority HPRA & other regulatory audits.
• Review...
Cpl Resources - LimerickTipperary
release Proven leadership and people management experience Desirable Experience supporting both commercial and clinical/IMP manufacturing Prior involvement in regulatory inspections (HPRA, EMA, FDA, etc.) Budget management and strategic QA leadership...
Grifols, S.ADublinappcast.io
controls and assess impact of changes that affect validated systems and define validation requirements
• Represent Validation at both internal and external audits by regulatory agencies, including HPRA and FDA.
• Generation and review of CSV project...
Trinity College DublinDublin
and national legislation (SI 543 of 2012), with the Health Products Regulatory Authority (HPRA) designated as the Competent Authority under Directive 2010/63/EU. It provides critical infrastructure and technical expertise to support key scientific research...
Summit Therapeutics Sub, Inc.Irelandappcast.io
management, and risk assessments for EU qualitysystem.
Ensure compliance with EU GMP, ICH guidelines, HPRA, and EMA regulatory requirements.
Provide leadership on quality assurance (QA) and quality management system (QMS) initiatives.Ensure SOPs and quality...
Phibro Animal Health EuropeSligojoblookup.com
Site Director
Reports To
VP, Operations
The Site Director is responsible for the operation, governance and strategic development of the vaccine manufacturing site in Sligo, Ireland. The facility operates under EU GMP, is licensed by the HPRA and plays...
CPLSligocpl.com
complies with the requirements of Veterinary Medicinal Directive 2019/6.
Ø Support preparation for supervising competent authority HPRA and other regulatory audits.
Ø Review relevant modifications of the Quality Management System (QMS), including new...
BardenCorkjoblookup.com
and ICH Q10 principles.
• Act as a primary QA contact with HPRA, MHRA, and other competent authorities during inspections, audits, and regulatory interactions.
• Ensure all aspects of product release, distribution, and market quality align...
AbbVieWestportjoblookup.com
Systems, Electrical Engineering, or a related area
• 8–10 years of experience in FDA/HPRA-regulated pharmaceutical or biotech environments.
• Proven leadership experience in managing projects and people.
• Strong technical skills in batch processing, SCADA...
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