...Compliance Specialist - Technical Operations
Location: On site / Limerick, Ireland
job type: Permanent / Full-time
Sector and subsector... ...good manufacturing practices (cGMPs) and execution of any other GMP compliance related activities as required.
Knowledge, skills...
Suir Engineering
Munster
2 days ago
...Quality Compliance Specialist - Change Control
We are currently looking to fill a Quality Compliance Specialist - Change Control position... ...procedures, reports and regulations to make decisions in GMP environment
Proven track record of establishing and maintaining...
Regeneron Pharmaceuticals, Inc
Munster
13 hours ago
...Principal Scientist - Quality Control Compliance page is loaded Principal Scientist - Quality Control Compliance
Apply locations Ireland... ...incorporated into the lab systems and processes.
Monitoring of GMP and compendial compliance.
Own the GMP readiness plan for the...
Eli Lilly and Company
Munster
1 day ago
...Summary: The Quality Compliance Coordinator supports data trending, process monitoring, and system administration activities to ensure overall good health of the Quality Management System (QMS). This position will focus on Deviation, CAPA, Change Control and Quality Risk Management...
Regeneron Pharmaceuticals, Inc
Munster
1 day ago
...Summary: The Quality System Specialist participates in maintaining site compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Engineering, Materials Handling, and QA Validation in...
Regeneron Pharmaceuticals, Inc
Munster
2 days ago
...Within this role you will be performing all compliance related tasks necessary to complete investigations and implementation of robust corrective actions for supporting manufacturing and site operations. Providing compliance expertise throughout the Engineering, Automation...
Regeneron Pharmaceuticals, Inc
Munster
2 days ago
...IT Compliance Analyst (Quality Assurance)
Within this role you will be responsible for ensuring that the IOPS IT group is operating in compliance with Regulatory requirements and Regeneron internal procedures as well being the key liaison between the IT and Quality Assurance...
Regeneron Pharmaceuticals, Inc
Munster
1 day ago
...this role you will be responsible for working with cross-functional teams to drive activities that will ensure a state of continuous GMP compliance in Regeneron IOPS and to build inspection readiness capability across the organization. This role will help to build mechanisms...
...at Janssen Biologics as required by Good Manufacturing Practice (GMP). These activities include Incoming material release, Batch release... ..., Supplier qualification, Annual product review and Validation compliance activities.
Provides support and direction to all departments...
Cpl Healthcare
Munster
4 days ago
...assurance team and ensure the highest standards of product quality and compliance.
Position Summary: The Qualified Person (QP) plays a pivotal... ...certification.
Ensures that the principles and guidelines of GMP as stated in 2003/94EC, 2001/83EC, 536/2014 (repealing 2001/20/EC...
Eli Lilly and Company
Munster
2 days ago
...Estimates, and Schedules, ensuring alignment with safety, environmental, GMP, and financial requirements.
• Directs project detailed design,... ...-effective execution of Capital projects, meeting customer and compliance requirements.
Core Competencies / Skills
• Project...
Asset Recruitment
Munster
5 days ago
...changes
Supporting equipment investigations to drive reliability and performance
Ensuring all areas of responsibility are compliance with GMP regulations
Promoting and ensuring safe working environment
Coaching and developing direct reports
Working closely...
Regeneron Pharmaceuticals, Inc
Munster
5 days ago
...current and future needs.
Within this role the Snr Distribution Compliance Specialist will ensure that the external warehouse network is... ...logistics partners to deliver on the above business requirements in a GMP environment, functioning as part of Supply Chain Logistics and be...
Regeneron Pharmaceuticals, Inc
Munster
2 days ago
...maintenance activities to maintain the assets of the company in compliance with cGMP and to ensure equipment is available, maintained & repaired... ...response to follow-up.
• Establish and maintain safety, GMP and Environmental Standards.
People Management:
• Ensures training...
ICDS RECRUITMENT CONSULTANTS LTD
Munster
1 day ago
...review and process audits to ensure batches are manufactured in compliance with regulatory requirements, company policy and procedures.
Essential... ...batches for accuracy, completeness, and compliance to GMP and procedural requirements.
Review of Standard Operation Procedures...
Cpl Healthcare
Munster
3 days ago
...support standardisation.
• Assist Maintenance & QA by performing compliance checks within the CMMS e.g. audit trail review.
• Highlight... ...CMMS expert.
• Carry out internal audits and periodic reviews of GMP activities to ensure compliance, to identify improvements and lead...
ICDS RECRUITMENT CONSULTANTS LTD
Munster
1 day ago
...calibration of instruments & equipment across entire site, including compliance and management of contracts and projects. Responsible for day-to-... ...; Submitting purchase requisitions as required
Ensuring that GMP and Regulatory requirements are complied with as evidenced by...
Regeneron Pharmaceuticals, Inc
Munster
3 days ago
£43.16k - £60.43k per annum
...Cultivate a proactive safety-first culture throughout manufacturing operations.
Design and enforce rigorous safety protocols, ensuring compliance with both local and global standards.
Lead periodic safety audits, undertaking comprehensive risk assessments and promptly...
Munster
7 days ago
...conformances are effectively recorded/actioned/closed
· Implement and manage the Quality Management System, generating and approving relevant GMP documentation, and managing risks, quality events, and CAPAs
· Manage specifications for all products and implement a regular...
Cpl Healthcare
Munster
4 days ago
...industry, infant formula, or wider food industries.
•Experience of managing a large team (people management);
•Proficient in applicable GMP/QSR regulations;
•Ability to deal with ambiguity and develop bespoke Quality Systems;
• Quality Systems Audit experience;
• Good...
Cpl Healthcare
Munster
1 day ago
...Operations, the Site Training Lead and Site Stakeholders to ensure that the integrity of the training system is maintained and compliant with GMP (Good Manufacturing Practise) regulations.
This includes data entry, receiving and processing LMS change requests, troubleshooting...
Cpl Healthcare
Munster
4 days ago
...maintenance-based activities including Corrective / Preventative / Production Support / Calibrations / Electrical work, in accordance with site GMP (good manufacturing practices) and safety standards.
Mechanical fitter responsibilities to include maintenance and repair of...
Cpl Healthcare
Munster
5 days ago
...schedules & routines for new equipment in the facility.
Responsibilities:
Liaise with vendor to determine maintenance strategy for new GMP equipment.
SLA to be developed to suit business needs.
Develop preventative maintenance routine for new equipment.
Track and...
Tandem Project Management Ltd.
Munster
2 days ago
...documented, assessed and completed.
Prepare Annual Process and System Reviews.
Act as lead/team auditor to support the internal GMP walkdown and scheduled audits.
Participate in the generation and communication of quality metrics.
Creation, review and approval...
Orion Group
Munster
2 days ago
...systems, electronic batch records, or manufacturing execution systems
Experience in a manufacturing environment
Experience in a GMP environment
Find working in an ambiguous environment with changing priorities exciting
Enjoy exploring technology and asking process...
Regeneron Pharmaceuticals, Inc
Munster
3 days ago
...Job Description - Utilities Engineer, GMP Utilities (2406182732W)
Utilities Engineer, GMP Utilities - 2406182732W
Description... ...Design, develop, and maintain GMP Utilities & Water Systems in compliance with industry regulations
Conduct regular inspections and audits...
Johnson & Johnson
Cork
3 days ago
£47.48k - £69.06k per annum
...with Company's and our Client's stringent safety standards
Liaise with our Client's during installation to ensure safety and quality compliance
Requirements:
The successful candidate must have the ability to work on their own initiative or as part of a team with minimal...
Munster
10 days ago
...equivalent with 2+ years relevant administrative & data entry work experience to support responsibilities of position.
Experience in a GMP, SOP, ISO, or similar regulated environment strongly desirable.
PC literate with prior experience utilizing MS Word, Excel and other...
Regeneron Pharmaceuticals, Inc
Munster
3 days ago
...assisting with strategic planning for the Regeneron Industrial Operations and Product Supply (IOPS) Quality Auditing function. Quality (GMP) Auditing is responsible for maintaining the external audit program and performing external audits for Regeneron IOPS, with primary...
Regeneron Pharmaceuticals, Inc
Munster
1 day ago
The QC Compliance Specialist will be responsible for managing QC's Change Controls/CAPAs and Workflows.
In this role a typical day might include, but is not limited to, the following:
Coordination and documentation of QC quality records including but not limited to, Change...