Search Results: 289 vacancies
£51.3k - £64.2k per annum
...management will be a distinct advantage.
* Must possess knowledge of pharmaceutical and/or medical device regulatory requirement for FDA and IMB regulated environments.
* Carry out supervisory responsibilities in accordance with the organization's policies and applicable...
County Galway
1 day ago
...maintenance program, troubleshoot and resolve malfunctions, propose equipment solutions, report anomalies, ensure regulatory compliance (FDA, IMB, GMP, Safety, and Environmental legislation), and conduct onsite equipment calibration. By fulfilling these responsibilities THE...
...quality metrics, e.g. NC, CAPA, Process Changes, , Quality Alert, Product Holds and Recalls.
Support site during External Audits. (i.e. FDA, IMB and BSI).
Responsible for input to Quality Metrics.
Ensure quality system updates
What you will need:
Degree Qualified...
£41.1k - £44.5k per annum
...people management experience.
* Experience of environmental monitoring and bacterial endotoxin testing Familiarity and understanding of FDA and EU pharmacopoeial requirements.
* Evidence of an acquired solid background of technical knowledge and experience, plus successful...
County Mayo
2 days ago
...Audit standard at all times, this includes but is not limited to all notified bodies associated with the Tullamore plant, e.g. FDA, ISO, TUV, IMB, ENHESA, NSAI and IDA.
Ensure site production trainers fully trained and competent.
Developing best practices to reduce the...
£64.54k per annum
...Excellent interpersonal, communication and team leader/member skills at all levels of the organisation.
Working knowledge of Quality Systems (FDA/ISO) within a regulated environment, and ERP/ASCP (SAP preferred)
High understanding of Supply Chain Finance.
Good Manufacturing...
Ireland
17 days ago
£29.9k - £42.8k per annum
...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 Monitoring.
* Experience...
County Mayo
2 days ago
...active participation in the validation of site Facility, equipment, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
* Generation/maintenance/execution of the Site Validation Master Plan, Project Validation Plans...
County Sligo
1 day ago
£42.8k - £47k per annum
...Demonstrable understanding and application of the fundamental principles of Medical Device Risk Management within the regulatory framework of FDA 21 CFR 820.30.
* Demonstrable understanding and application of Design, Use and Manufacture risk-related analysis methodologies,...
Dublin
2 days ago
£50k - £60k per annum
..., including OEE where applicable
* Provide direct interface as a subject matter expert with the QA department to interact with HPRA, FDA and applicable health authorities and internal audits.
What you need to apply:
* Minimum of 5 years experience in batch processing,...
County Mayo
2 days ago
£51.3k - £59k per annum
...procedures, including safety and training.
* Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards).
* Assist in the development of any existing validation program to ensure continued compliance to the...
Dublin
2 days ago
...validating, and revalidating all CGMP equipment, systems, and processes to meet global standards and regulatory requirements set by the FDA, HPRA, and other relevant authorities.
Key Responsibilities:
* Ensure compliance with validation requirements for new processes,...
Westport, Co. Mayo
24 days ago
...business problems, develop business cases, and identify appropriate process and technological solutions is critical.
* Expert Knowledge of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals in particular Annex 11 & 21CFR Part 11.
* Excellent...
Cork
16 days ago
£ 43 - 56 per hour
...vendor package owner for large construction projects
· Great communicator and team player
· Knowledge of risk based (ASTM E2500) approach to CQV
· Experience of working to deadlines within a time critical environment
Working knowledge of US FDA & EU GMP regulatory requirements
County Sligo
23 days ago
...*
Bachelor's degree in Computer Science, Engineering, or a related field.
*
Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
*
Experience in computer system validation within a regulated industry, preferably pharmaceuticals...
Dublin
15 days ago
...interface with research & development
• Direct experience interacting with Health Authorities and supporting Health Authority inspections, specifically FDA and/or EMA
• Experience in interacting with external manufacturers and supporting quality at external manufacturing sites
Dublin
4 days ago
...Qualifications & Experience
A 3rd Level Qualification in Automation Systems or Mechatronics
Relevant working knowledge of an FDA regulated industry and GMP requirements.
Experience working in a Cleanroom environment
Previous experience working with a CMMS (preferably...
...improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.
At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of...
...improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.
At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of...
...system improvements.
Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements,...
