...life cycle. You will participate in a variety of activities, such as, but not limited to, preparing or authoring CMC regulatory investigational, commercial and post approval submissions, representing the company on communications and in meetings with health authorities, assessing...
Pfizer
Adare, Co. Limerick
4 days ago
....
* Develop, set up and manage the process for Site Waste Management Plan for all construction projects.
* Pollution incident investigation and reporting to Environment Agency.
* Advising on effective compliance with Environmental management system held at international...
Tarbert, Co. Kerry
2 days ago
...that the company, GMP and relevant regulatory requirements have been met
~Review and approve change controls, deviations, failure investigations, suspect analytical results, product quality complaints, stability studies and reports associated with the manufactured batches
~...
...individual who is looking for the next step in their career.
Your Key Responsibilities:
Use case management software to capture, investigate and respond within timescales to queries (employee, business, HR).
As part of an agreed rota work closely with wider HR/...
€50k - €60k per annum
...Contribute and participate in the assignment of equipment priorities, planning and scheduling, maintenance plans, reviews and failure investigations
Engage directly with manufacturers and suppliers of parts to ensure timely and efficient availability of port equipment as...
...Expert (SME) and act as the key point of contact for internal partners and external MLROs on financial sanctions related matters.
Investigation of Unusual Activity Reports and submission of reports to the relevant authorities;
Provide advice to the first line partners...
€50k - €60k per annum
...follow-up actions.
Training needs analysis and development/implementation of training programmes
Leading incident reporting investigations
Continuous development and implementation of the companies Emergency Response Plan.
Experience Required
4+ years’ experience...
...and yield/efficiency improvement projects/opportunities.
Support the post market surveillance of devices in terms of complaint investigation and risk analysis.
Support the supplier change notification process to ensure supplier related changes are implemented successfully...
...documents such as: SOPs, material specifications, protocols, and trend reports (water, environmental monitoring, etc) and performs investigations as needed.
Understand integration of process parameter requirements with MES/electronic batch records to ensure all regulatory,...
...report back to the Clinical Nurse Manager / Booking Coordinator on any aspect of service user care which he / she feels warrants investigation or urgent action.
6. To participate in reviews of service users support service as required. To be aware of the tasks and activities...
...are carried out and all training is up to date on ‘Go Contractor’ for CJV operatives and any subcontractors working in your area
Investigate and prepare reports on any accidents, injuries, near misses and dangerous occurrences, report to the Health and Safety Manager...
...Perform instrument calibration and maintenance and review and approval of associated documentation as required.
Initiate laboratory investigations in a timely manner as required.
Comply with GLP/ GMP and safety requirements at all times
Maintain laboratory in a clean and...
€50k - €55k per annum
...decisive action when necessary.
Organize and deliver training sessions to management and personnel as required.
Lead incident investigations and ensure appropriate corrective actions are identified and implemented.
Facilitate meetings between safety representatives,...
..., but not limited to the following:
Supporting and conducting engineering and metrology research including the identification, investigation and implementation of new advanced metrology and inspection systems and technologies
Coaching and advising all engineering groups...
...Microbiologist for a permanent role. The successful candidate will play a crucial role in global pharmacovigilance activities related to our investigational products portfolio. This includes reviewing and analysing safety data from non-clinical and clinical trials, ensuring quality...
...Facility in Co. Limerick..
Essential Duties and Responsibilities include, but are not limited to, the following:
Completes investigations of technical deviations for department issues of non compliance. Ensures CAPAs are identified as appropriate and are implemented...
...and tracking IP shipments, temperature excursions, and product expiry for molecules across multiple Therapeutic Areas
~ Tracks investigational product (IP) inventory.
~ Independently initiates IP shipment orders according to supply plans or as requested by Clinical Logistics...
€50k - €70k per annum
...animal work can be tailored to suit the individual candidate.
The ruminant work would be be 50% ambulatory clinical work and disease investigations, and 50% ambulatory routine work such as tuberculosis testing, ultrasound scanning, diagnostic sampling for herd health, bull...
...excellent service to our network of clients.
The key responsibilities of the role include:
Ensuring all complaints are investigated promptly and within strict timeframes, treating all customers fairly to retain the professionalism and integrity of Northern Trust....
...and efficacy.
Cost reduction and yield/efficiency improvement opportunities.
Provide engineering input and support for the investigation and resolution of Non-Conformances associated with devices post release to market.
Support Regulatory Affairs as required with...
...- Revanista.
To assist with the alignment of Revanista's software development with the business strategy.
Trouble shoot and investigate any systems errors or data discrepancies as needed.
Carry out tests and checks of systems as directed to ensure all is working correctly...
...To ensure all Health & Safety statutory requirements and Fire procedures are complied with and that incidents are reported and investigated in accordance with established (HSE & HIQA) standards and requirements.
To assist in the process of Clinical Risk Management....
...requirements.
Develop/Review product assessments for adoptions to the available EO Sterilisation cycles.
Work with Stakeholders to investigate process related non-conformances.
Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s...
€50k - €60k per annum
...internal audits and inspections to assess compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.
* Investigate deviations, non-conformances, and customer complaints, leading root cause analysis and implementing corrective and preventive actions...
AVANSEL RECRUITMENT IRELAND
Limerick
more than 2 months ago
...for existing devices (i.e. dFMEA, Risk Benefit Analysis).
Support the post market surveillance of devices in terms of complaint investigation and risk analysis.
Provide engineering support for post market clinical studies if required.
Work with CAPA team as required...
...communicated and implemented throughout the Company.
Liaise with enforcement authorities if they attend a site on routine visits or to investigate following an incident.
Build and maintain effective key relationships with other departments and 3rd parties.
Project work as...
...approved schedules.
Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
Reviews,...
...relevant regulations.
~Collaborate with production and QC teams to ensure product quality throughout the manufacturing process.
~Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain product quality.
Regulatory Compliance...
...Utilize appropriate complaint software systems for processing complaints to/from customer support and delivery centres and QE Investigation functions.
Generate appropriate regulatory reports based on assessment.
Liaise effectively with regulators on all issues with...
...communicating Method
Statements, Safe Plans of Action and Tool Box Talks.
Ensure that all accidents are reported, recorded and investigated and that suitable notification is given to the Directors, Health & Safety Authority and Insurers as required
Producing weekly...
Morgan McKinley
Limerick
2 days ago