£41.3k - £44.7k per annum
...perform and review laboratory investigations.
* Assist in the creation and maintenance of laboratory SOPs and validation documents for GMP lab test procedures and systems.
* Assist in the writing of functional area status reports, regulatory documents, and process...
County Mayo
10 days ago
£50k - £60k per annum
...the company at client and regulatory meetings and audits.
* Ensure all activities in the department are performed in accordance with GMP, relevant SOP’s and policies.
* Participate in management activities within the operations group to ensure timely and appropriate availability...
County Mayo
10 days ago
£30.1k - £43k per annum
...required or equivalent science discipline.
* 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...
County Mayo
10 days ago
...required or equivalent science discipline.
* 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...
Team Horizon
County Mayo
15 hours ago
...environmental, health, and safety goals by adhering to all general site and department safety policies.
Essential Behaviours:
Adhering to GMP cleanroom behavioural procedures at all times.
Completing all GMP paperwork RFT, in a timely manner and as per GDP, allowing for...
...data and trends.
Requirements:
~ Third Level Degree in a Science, Quality or Engineering discipline.
~5+ Years of experience in a GMP Environment with 3+ years of experience in support of Aseptic Manufacturing ideally.
~ Strong knowledge of Regulatory Requirements....
...coordinating key activities and improvement efforts across the Utilities Services.
* Drive and lead projects to meet Safety, Environmental, GMP, Production and Financial Objectives.
* Ensure compliance with all regulatory & standards when completing projects.
* Ensure...
Team Horizon
County Mayo
2 days ago
...managing relationships with clients and suppliers.
~ Familiarity with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
~ Strong organizational skills.
~ Effective communication abilities.
~ Detail-oriented approach to work.
For a...
...Secretarial or computer Certificate/Science Diploma or equivalent (preferable but not essential)
Documentation control experience ideally in a GMP/GLP environment would be an advantage
An equivalent combination of education and experience may be accepted as a satisfactory...
...Receipt and processing of test samples in LIMS.
Safe and compliant disposal of all laboratory generated waste.
Generation of GMP compliant SOPs, Protocols and reports.
Carry out data calculations and basic statistics.
Assist in internal, regulatory and client...
...immunological methodologies to meet client requirements and/or company strategic objectives.
Draw up study plans / protocols ensuring full GMP regulatory compliance, where appropriate.
Execution of study plans and / or complex methods in the laboratory for transfer /...
...within the required timelines i.e. scheduling of tests, review of basic data, liaising with QA, generation of CoA etc.)
Generation of GMP compliant SOPs, Protocols and reports.
Sourcing, purchasing and stocking consumables, standards and reagents required for testing....
...perform. In return, we’ll help you build a career that you can feel passionate about.
Job Summary
Do you have expertise in working to GMP standards, within a Quality Assurance function?
Are you a motivated people leader, with the desire to play a key role in career...
...Your Key Activities will include, but are not limited to:
~ Carry out daily tasks as assigned by the Production Manager according to GMP and the quality system
~ Perform activities associated with the compounding, filling and capping of an aseptic process.
~ Prepare components...
...the generation of all departmental quality documents including audit responses, facility replies and deviation reports.
-Generation of GMP compliant SOPs, Protocols and reports
-Generate risk assessments for laboratory and test items as required.
-Maintain Laboratory Data...
...Science, Quality or Engineering discipline.
• 2-3 Years of QA or Microbiology (Environmental Monitoring, Sterility) experience in a GMP Environment with experience in support of Aseptic Manufacturing ideally
• Strong knowledge of Regulatory Requirements
• Excellent...
...Training Specialist to join our team for a 6 month contract on our site in Westport . This person will play a pivotal role for all QA/GMP training activities in support of all aspects of commercial, clinical and development activities at the site. Reporting to the Senior...
...experience preferred
~ Understanding requirements of cross contamination controls in multi-product facility
~ Knowledge and experience with GMP regulatory inspections
~ Excellent report / procedure writing skill set required
~ Working knowledge of Quality Management System (...
...Bachelor's degree in IT, Computer Science, Mechatronics, Electronics, or similar
~9+ years relevant industry experience. Exposure to FDA, GMP, ISA95, safety and environmental legislation. Experience in the pharmaceutical or life sciences industry is preferred
~5+ years of...
...the QC Manager.
Responsibilities:
Provide guidance to direct reports to ensure activities are completed as per schedule and in a GMP compliant manner and in line with regulatory (QA and EHS) and corporate requirements.
Maintain strong relationships with management...
...activities and improvement efforts across the Utilities Services.
Drive and lead Technical Services to meet Safety, Environmental, GMP, Production and Financial Objectives.
Deliver performance aligned to the Perfect Index.
Develop a strong team of engineers, clearly...
...with ICH guidelines, where appropriate.
Draw up study plans and implement studies in strict accordance with study plan ensuring full GMP regulatory compliance as appropriate.
Liaise with the Quality Department for the generation of audit responses, deviation reports...
...Management.
As part of a team, you will be responsible for ensuring that drug product manufacturing is performed in compliance with site and GMP procedures, and that scheduling and manufacturing meets global request timelines. Flexibility around shifts will be required.
If...
...Support update current standard operating procedures.
Assist in laboratory investigations where necessary.
Support generation of GMP compliant SOPs, Protocols and reports
Generate risk assessments for laboratory and test items as required.
Maintain Laboratory Data...