Search Results: 235 vacancies
...Senior Computer System Validation Engineer required to Lead Quality, Compliance & CSV by innovative MedTech company in Galway
Responsibilities:
Lead Quality and Compliance activities in relation to Software projects.
Ensure Quality and Compliance with respect to...
...clients are predominantly business owners who are focused on ensuring their day to day operations perform as they should, I.T, networks, systems and cybersecurity are generally not something they have time to consider and that is where we step in. We manage all of the I.T....
SPEEDECK
Galway
3 days ago
Job title: Senior R&D Engineer – Control system
Location: Parkmore, Galway
Company:
My client are a medical device company developing a new and innovative device to support the heart. Heart support devices are used by interventional cardiologists to stabilize patients...
...implementation of appropriate supporting documentation, which complies with GMP in conjunction with the other team members.
Project planning,... ...and complies with all the regulations governing the quality systems.
Ensures all direct reports are aware of their commitment to...
...the routine maintenance of Quality and other business Management Systems.
Responsibilities:
Possesses and applies a fundamental and... ...Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP),
Awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL...
...responsible for implementing, maintaining the quality management system, ensuring effective compliance in accordance with regulatory requirements... ...competence.
~ Detailed knowledge of FDA QSR (21 CFR Part 820), GMP, MDSAP, IVDR and ISO 13485.
~ Solid communication and...
...strategies to ensure continuous growth of personnel and quality systems improvements.
Demonstrate strong leadership and a clear identifiable... ...and efficiency of processes.
Overall responsibility for GMP standards and compliance within company’s Project Teams and Supplier...
...principles.
Work within a highly regulated environment ensuring highest product quality is achieved through robust quality system processes such as GMP, NCR and CAPA etc.
Improve the production flow to achieve quality at source, rapid feedback from inspections....
...agreed requirements
Ensure effective and timely closure of Quality system documentation (Audit Actions, NC’s, CAPA’s, Reject Report’s etc)... ...and quality systems improvements
Overall responsibility for GMP standards and compliance within manufacturing
Drive risk management...
...2/EEC and 2007/47/EC and the Companies Medical Quality Management System.
Main Duties & Responsibilities
Build sub-assemblies and finished... ...were cleanroom-based).
Demonstrated experience with GDP & GMP standards is advantageous.
Work Experience/Training Provided...
...Proficiency with CAD software (Solidworks) is required.
~ Experience of medical device regulations including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations) and ISO quality requirements is required.
~ Strong initiative and follow through in executing...
...machine faults through experience with Electrical and Pneumatic systems
Demonstrated process and continuous improvement mindset
Excellent... ...or as part of a team
Strong commitment to Quality, safety and GMP standards.
N.B. It is essential that you hold a valid working...
...machine faults through experience with electrical and pneumatic systems
-Demonstrated process and continuous improvement mindset
-Excellent... ...strong work ethic.
-Ability to work independently or as part of a team
-Strong commitment to Quality, Safety and GMP standards....
...lines in a time frame in all production areas.
Working nights and including Sunday as working week.
Adherence to procedures –
· GMP – Daily hygiene and housekeeping,
· Good Housekeeping is essential.
· Cleaning instruction cards – ensure cleaning instruction...
...testing.
Strong computer skills in MS Office.
Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines.
Apply now
If you are interested in learning more or applying to this exciting opportunity then please click...
...Position
4 DAY WEEK
Hours : 06.00 - 4.15pm Mon-Thurs
Key Roles & Responsibilities
Work in a clean room environment and demonstrate GMP (Good Manufacturing Practice) & GDP (Good Documentation Practice) in all elements of their work ensuring high standards are maintained,...
...city.
Key Roles & Responsibilities
Perform work in a controlled cleanroom environment, adhering to Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) to ensure high standards are maintained.
Follow work procedures and specifications carefully...
...Leadership skills with the ability to manage multiple priorities.
A strong understanding of medical device design, regulations (e.g., GMP, QMS, ISO), and design control processes.
For more details on this role, feel free to reach out to me ****@*****.***...
...will support the Team Manager in setting up a new Microbiology laboratory . The ideal candidate will be a Microbiologist with proven GMP experience.
Overview of your responsibilities (full job description available on request):
Managing Analysts and communicating...
£77.69k - £103.59k per annum
...clients.
You will have comprehensive understanding of the SDLC with previous experience developing, ideally in C++, Source Control systems, development tools, and processes. While this will be a hands-off role in terms of development, you will take code reviews and source...
Galway
2 days ago
