HPRA Jobs
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Health Products Regulatory AuthorityDublin
will be exposed to three key work programmes at the HPRA that focus on the medicines on our market.
The Company
We are the Health Products Regulatory Authority (HPRA) and we regulate medicines and devices for the benefit of people and animals. We are committed...
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WuXi Biologics Ireland LimitedDundalk
HPRA, EMA, FDA, client audits), ensuring documentation, systems, and practices are audit-ready. Uphold standards of Good Documentation Practice (GDP) and ALCOA+ compliance. Provide technical support to Operations (QC, Utilities, Warehouse, Cell Culture...
Eli Lilly and CompanyCork
are desirable.
Experience:
• 10+ years with leadership in quality, compliance, data governance, and lab systems validation and quality assurance.
Required Skills:
• Strong working knowledge of FDA, EMA, HPRA, MHRA, and other regulatory authorities for data...
Collins McNicholasMullingar
scope for impact. Key Responsibilities: Plan, schedule, and conduct internal and external audits (manufacturers, suppliers, labs, warehouses, transporters). Review documentation and quality processes to ensure compliance with HPRA, EU, and US GMP/GDP...
Sligo
A good knowledge of aseptic processes' manipulation together with experience within a GLP/GMP environment and knowledge of current EU/FDA/ICH/HPRA guidelines.
Lab experience within industry – Bioburden / Endotoxin / Growth Promotion / Environmental...
cv-library.ie -
Alliance Medical Diagnostic Imaging LtdDublin
batch manufactured by Alliance Medical Ireland is tested and certified in compliance with GMP and HPRA guidelines before release to market. Responsible for managing a small team, with early routine production times. Duties to Include: Coordinate and lead...
Collins McNicholas RecruitmentTullamore
with HPRA, EU, and US GMP/GDP standards.
• Assess quality systems (QMS), including document/change control, deviations, and CAPA management.
• Identify non-compliance issues, recommend corrective actions, and ensure timely follow-up.
• Prepare clear audit...
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6 similar jobs: Kilkenny, Longford, Mullingar, Wexford, Dublin...
Gertek Project ManagementBallina (County Mayo)
projects. Proficient 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 and regulatory requirements...
Jones Lang LaSalle IncorporatedIreland
infrastructure. This position directly impacts the production of life-saving medications and medical devices by maintaining critical building systems, cleanroom environments, and controlled atmospheres that meet stringent FDA, EMA, and HPRA standards.
As a key...
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WuXi Biologics Ireland LimitedDundalk
and regulatory inspections (HPRA, EMA, FDA, client audits), ensuring documentation, systems, and practices are audit-ready. Uphold standards of Good Documentation Practice (GDP) and ALCOA+ compliance. Provide technical support to Operations (QC, Utilities...
TEAM HORIZONDublin
or not with regulatory requirements in our current markets and liaise with non-compliant potential suppliers.
Maintain audit-ready product database for customers and HPRA assurance.
Maintain organized and up-to-date regulatory files, records, and documentation, ensuring...
Collins McNicholasAthlone
scope for impact. Key Responsibilities: Plan, schedule, and conduct internal and external audits (manufacturers, suppliers, labs, warehouses, transporters). Review documentation and quality processes to ensure compliance with HPRA, EU, and US GMP/GDP...
DHL Supply ChainDublin Pike
and participating in the implementation of projects from a quality and regulatory point of view. Also, you will -
Compliance across the business with all HPRA/Department of Health requirements and aim to eliminate non-compliance findings during regulatory...
1100 Mylan Pharmaceuticals Inc.Portlaoise
environment.
• Previous experience of managing a technical team in an R&D environment.
• Experienced in writing regulatory submissions.
• Experienced in leading a technical team in support of FDA, HPRA or notified body inspections
• A working knowledge...
6 similar jobs: Longford, Wexford, Mullingar, Kilkenny, Dublin...
Alexion Pharmaceuticals, Inc.Dublin Pike
To Have A minimum of 2 years’ experience in Manufacturing Operations in a Pharmaceutical or Biopharmaceutical company, ideally with experience in both upstream and downstream processing.
Good knowledge of GMP/HPRA/FDA regulatory requirements.
Strong...
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