Search Results: 81 vacancies
£ 47 - 51 per hour
...of Process systems; Centrifuge, Parts Washers, Autoclaves.
* An understanding of applicable regulations such as Annex 11, GAMP and 21 CFR Part 11.
* 7+ years’ experience in a GMP environment, preferably Pharma/Biopharma.
* Strong problem solving skills.
* Ability to...
Dublin
9 days 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
2 days ago
£ 43 - 56 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
2 days ago
....
* Ability to work independently with minimum direct supervision.
* Experience of Pharmaceutical Industry Regulations cGMP/cGLP, 21 CFR 11 and EU Annex 11 compliance requirements.
* Experience working with all disciplines in and supporting a Laboratory environment including...
Sligo, Co. Sligo
22 days ago
£42.7k - £47k 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
1 day 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
14 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
8 days ago
...3rd party vendors. Work closely with CCC and CMC managers to establish and ensure compliance with applicable regulations (e.g. FDA 21 CFR Part 820.198, FDA 21 CFR Part 803, ISO 13485:2003), company and department policies and procedures.
Key Responsibilities
Act...
...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...
€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...
€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
20 hours ago
...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...
€55k - €65k per annum
...redundancy design.
Excellent written and verbal communication skills.
Good understanding of current good manufacturing practices, 21 CFR Part 11, 210 and 211, and Annex 11
General knowledge of network configuration, computer hardware and software, including automation...
...the quality system that ensures its suitability, adequacy, and effectiveness.
Ensure the compliance with cGMP, ISO 13485, and FDA 21 CFR Part 820 regulations.
Oversee QA support in the review and approval of plant related validation protocols, reports, and change...
..., documentation and maintenance of the quality system to be compliant with, as appropriate, the following standards: ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards . This role leads the local site...
...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...
...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...
Headcount Solutions Limited
Dublin
1 day ago
...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
~ Strong communication skills...
€40k - €65k per annum
...industry, preferably with Medical devices.
Strong understanding of design control principles and regulations, including FDA QSR (21 CFR 820) and ISO 13485
Experience with risk management methodologies, such as ISO 14971, and application to medical device development....
€60k - €75k per annum
...medical industry a prerequisite. Auditor certification from an industry recognized organization is beneficial.
~ Knowledge of FDA's 21 CFR Part 820 (Quality System Regulation) and ISO 13485:2016
~ Experience in the QA activities associated with the design and development...
