...The Role
We have an exciting opportunity within our Biologics Division located in Ballina, Co. Mayo, Ireland for a Quality/Regulatory Compliance Manager to join the team on a permanent, full-time basis. Reporting to the Senior Director, Regulatory Compliance, you’ll be responsible...
...methodologies to meet client requirements and/or company strategic objectives.
Draw up study plans / protocols ensuring full GMP regulatory compliance, where appropriate.
Execution of study plans and / or complex methods in the laboratory for transfer / validation / method...
...audits (MDSAP, ISO9001, ISO14001, FM Global etc.)
Ensure safety compliance within area of remit and supporting safety compliance and... ...other departments to schedule/coordinate work
~ Experience with regulatory compliance ISO9001, ISO14001 and ISO50001 preferred.
~2D/3D CAD...
...reporting progress information to Management.
-Assist in internal, regulatory and client visits/audits and respond to findings.
-Complete... ...items as required.
-Maintain Laboratory Data Integrity and compliance
Profile and Requirements
The following are minimum requirements...
...guidelines, where appropriate.
-Draw up study plans and implement studies in strict accordance with study plan ensuring full GMP regulatory compliance as appropriate.
-Liaise with the Quality Department for the generation of audit responses, deviation reports and for the...
...customers, and other plant stakeholders to set critical quality specifications for safety, to optimize OEE, supply chain, and regulatory compliance of packaging.
Organize and lead meetings with packaging suppliers to optimize efficiency.
Compliance: monitor, conduct...
Coca-Cola HBC
Ballina, Co. Mayo
2 days ago
...test items as required.
Maintain Laboratory Data Integrity and compliance.
Profile and Requirements
The following are minimum... ...in-vitro bioassays highly desirable.
Basic understanding off regulatory guidelines desirable.
Ability to problem solve and work on own...
...detail essential
Adopt a can-do attitude
About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies...
...Generation of GMP compliant SOPs, Protocols and reports.
Carry out data calculations and basic statistics.
Assist in internal, regulatory and client visits/audits and respond to findings.
Sourcing, purchasing and stocking consumables, standards and reagents required...
...characterize and measure the performance of the product
Providing technical R&D support to other functions including Global Marketing, Regulatory Affairs, Engineering and Manufacturing.
Managing project schedules, conducting product and project risk analysis and ensuring...
...calculations, basic statistics and trending. Provide additional information at the clients request as required.
Assist in internal, regulatory and client visits/audits and respond to findings.
Assist in the development and validation of different immunoassays (ELISA,...
...preparation of periodic results in accordance with US GAAP & Irish GAAP (journals, data reporting on both payroll and expenses).
Audit compliance – Support internal and external audit requests, providing information and ad-hoc requests.
On-boarding/New Hire Orientation...
...control project activities to fulfill project objectives and satisfy project / product requirements. Ensure team deliverables are in compliance with the company’s product development and quality processes.
Manage and track project budget, cost and profit targets to meet...
...Determine quality standards and specifications for suppliers
Collaborate with suppliers to implement quality improvements and ensure compliance with LGC's standards
Develop and maintain supplier quality agreements and performance metrics
Provide guidance and support to...
...in assigned projects.
Equipment Qualification – support / lead qualification of new production equipment / processes and ensure compliance to quality standards through execution of protocols.
Design & Implementation of testing protocols for new machines, testing that...
...drive operational excellence.
Monitor and enforce quality standards in all operational aspects, including cleanliness, safety, and compliance with relevant regulations and policies.
To have a thorough knowledge of agreed Hotel budgets and to ensure departmental targets...
€800 per day
...including provision of child protection, alternative care, specified regulatory services and a range of family support services. The Agency... ...and whether appointments should be confirmed.
~Ensure compliance with and implement HR policies and procedures and guidelines....
...balance sheet reconciliations
Drive process improvement initiatives to deliver on business objectives
Deliver full compliance with all regulatory requirements, including the support of external and internal audits.
Variance Analysis – monthly management accounts must...
Collins McNicholas Recruitment
Castlebar, Co. Mayo
17 hours ago
...and managing the Restaurant operations including budget management, team leadership & training, customer service, menu design, and compliance with health and safety regulations.
About The Diamond Coast
Located in Enniscrone, The Diamond Coast Hotel commands a prime...
...activities. Active management of all gaps in performance to ensure ongoing improvement.
Ensure daily activities are carried out in compliance with all appropriate safety, quality, and environmental standards.
Timely completion of all corrective and preventive actions to...
Coca-Cola HBC
Ballina, Co. Mayo
2 days ago
...systems, meticulously developing detailed product specifications and designs aligned with user requirements, production capabilities, and regulatory standards.
Cross-Functional Collaboration: Actively engage with internal teams, including Quality, Operations, Engineering,...
Collins McNicholas Recruitment
Castlebar, Co. Mayo
2 days ago
...business plan
Project Running Phase:
Manage your site team in the effective day to day running of site activities
Ensure compliance with program materials deliveries and engineering quality and safety issues
Attend meetings with Clients
Hold weekly progress...
...Health policies, procedures and regulations are followed
Identify opportunities for continuous improvement initiatives
Safety Compliance: Ensure that all workshop activities comply with relevant health and safety regulations, company policies, and industry standards....
...electrical sprinkler, structural and architectural elements
Review and understand project design specifications and drawings and access compliance of co-ordinated drawings and technical submittals.
Assist in the production of weekly progress reports
Assist in the...
€41.97k - €70.1k per annum
...results.
* Monitor microbial resistance and infection rates.
* Collaborate with healthcare teams for effective surveillance.
* Ensure compliance with quality standards.
Requirements:
* Bachelor's degree in Medical Laboratory Science.
* CORU registration.
* Post-graduate...
...and project managers to resolve any discrepancies, conflicts, or modifications to design requirements during the detailing process.
~Compliance with Codes and Standards: Ensure that all shop drawings comply with relevant building codes, industry standards, and regulations to...
€58.25k - €77.9k per annum
...results.
* Monitor microbial resistance and infection rates.
* Collaborate with healthcare teams for effective surveillance.
* Ensure compliance with quality standards.
Requirements:
* Bachelor's degree in Medical Laboratory Science.
* CORU registration.
* Level 9 post...
...relations issues, including conflict resolution and performance management.
Conduct investigations and recommend appropriate actions in compliance with company policies and legal regulations.
Talent Acquisition and Management:
Oversee the recruitment process, including...
Collins McNicholas Recruitment
Castlebar, Co. Mayo
17 hours ago
...manufacturing and suppliers to resolve issues and to disposition materials.
Work with Quality Manager to support audits with external regulatory agencies (Notified Body’s and Competent Authorities) and customers.
Write and review validation protocols and reports to support...
Recruit Island
Castlebar, Co. Mayo
3 days ago
...continuous safety improvements by encouraging feedback and implementing effective risk identification and mitigation strategies.
Ensure compliance with Environmental, Health, and Safety (EHS) requirements and achievement of EHS Key Performance Indicators (KPIs).
Collaborate...
Collins McNicholas Recruitment
Castlebar, Co. Mayo
1 day ago