Search Results: 73 vacancies
£29.8k - £38.3k per annum
...combination product/device manufacturing environment.
* Minimum 2 years working knowledge of quality systems regulations (ISO13485/ISO9000; CFR 21 Part 820) or individual elements within the regulations such as process validation, design controls, CAPA, auditing, etc., is...
Ireland
9 hours ago
£ 47 - 51 per hour
...ControlNet, DeviceNet, Profibus and OSIsoft PI Data Historian
* Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and 21 CFR Part 11
HOW TO APPLY
If you're interested in this role, click 'Apply Now' to forward an updated copy of your CV
Dublin
4 days ago
£ 43 - 55 per hour
...experience of batch processing and DCS platforms in a GMP environment in the pharmaceutical industry.
* 3 years’ experience of the 21 CFR Part 11 requirements for automated systems in the pharmaceutical industry.
* 3 years plus of Experience of plant start-ups and/or new...
County Sligo
27 days ago
£ 43 - 47 per hour
...experience with preference for following technologies: Siemens PLC/HMI
* Knowledge of GAMP software development lifecycle, S88/S95 industry standards and 21 CFR Part 11
HOW TO APPLY
If you're interested in this role, click 'Apply Now' to forward an updated copy of your CV
Waterford
4 days ago
£42.5k - £46.8k per annum
...to apply:
* Third Level Qualification Engineer or Designer with demonstrable understanding and application of Design Controls per 21 CFR 820.30 and Risk Management per ISO 14971:2019.
* 2-4+ years relevant experience is desirable but not essential.
* Demonstrable understanding...
Dublin
27 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...
Dublin
12 days ago
€50k per annum
...manufacturing environment
Preferred Knowledge, Skills and Abilities:
A thorough working knowledge of quality systems such as ISO 13485, 21 CFR Part 820 and/or EU GMP is essential. Knowledge of 21 CFR Part 210 / 211 would be considered an advantage.
Must have excellent...
Dublin
4 days ago
...Engineering or equivalent industry disciplines
Experience in medical device manufacturing regarding Quality System requirements per 21 CFR 820 and/or ISO 13485 preferred
Degree in Engineering/Science Discipline or related study
About Hollister Incorporated...
...Assurance/Systems engineer role within a relevant regulated industry plus demonstrated competence.
~ Detailed knowledge of FDA QSR (21 CFR Part 820), GMP, MDSAP, IVDR and ISO 13485.
~ Solid communication and interpersonal skills.
~ Demonstrated and impactful project...
...attention to detail.
Good working knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820 is preferred.
High self-motivation, self-starter with a passion for excellence.
Good working knowledge of Microsoft Office....
...pivotal role in establishing and maintaining a robust Q uality Management System (QMS) in compliance with EN ISO13485:2016, EU MDR and 21 CFR Part 820 regulations. You will oversee various quality assurance and regulatory activities, ensuring adherence to organisational and...
€50k per annum
...Device manufacturing environment.
A working knowledge of quality systems such as ISO 13485 is essential. Experience and knowledge of 21 CFR Part 820 and EU GMP is an advantage.
Team player who can work effectively and proactively on cross-functional teams.
Experience/...
Dublin
26 days ago
...knowledge of cGMP and regulatory requirements relating to the Pharma/Life Sciences manufacturing industry is essential as is knowledge of 21 CFR part 11, GAMP5 and ISA95
~ Strong communication (written and oral), presentation and troubleshooting skills required
~ Effective...
...Life Cycle).
~Good working knowledge of ISO13485 and ISO14971.
~IEC 62366 knowledge preferred (Usability).
~Understanding of MDR and CFR requirements.
~Prior experience with Jira/Structure/templated export or equivalent software tooling.
For further details please...
...externally with vendors such as CROs in feasibility, planning, initiation, maintenance and closeout of clinical projects according to GCP, ICH, CFR and Regeneron Standard Operating Procedures (SOPs). Travel to study sites may be required to assist with monitoring clinical studies....
...including the building, configuration, qualification and validation of servers and PC’s for use in a GxP environment according to GAMP 5 and CFR 21
• Additionally, the Lab IT Lead will assure full and continuous compliancy with regulatory and company requirements, for example...
...Minimum of 4+ years' experience in Quality in a regulated environment.
Knowledge of the regulatory and compliance requirements of FDA 21 CFR Part 820 QSR, ISO 13485:2016, EU MDR.
Familiarity with SAP, Veeva Vault and Trackwise would be desirable.
Fastnet has a strict...
...understanding of quality management system principles (e.g., ISO 9001 or ISO 13485) and/or FDA design and development processes to 21 CFR part 820.
· At least one year experience in electrical and/or mechanical verification (Design Verification Testing/ DVT), including the...
...Standards Knowledge: Familiarity with GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards, and compliance with 21 CFR Part 11 and Annex 11.
Soft Skills: Strong technical writing, communication, and presentation skills. Ability to work independently...
€35k - €45k per annum
...preferably in a regulated industry.
Familiarity with regulatory requirements and standards governing document control, such as FDA 21 CFR Part 11, ISO 13485, ISO 9001, or similar.
Excellent attention to detail and organizational skills, with the ability to manage...
