Search Results: 60 vacancies
...passionate about.
Job Summary
Do you have expertise in working to GMP standards, within a Quality Assurance function?
Are you a... ...located in Ballina, Co. Mayo, Ireland for a Quality/Regulatory Compliance Manager to join the team on a permanent, full-time basis....
£41.3k - £44.7k per annum
...documented procedures for Microbiological monitoring and responsible for compliance with documented procedures.
* Responsible for the identification... ...and maintenance of laboratory SOPs and validation documents for GMP lab test procedures and systems.
* Assist in the writing of...
£50k - £60k per annum
...Dose Compounding, Filling, within the business unit to ensure cost, compliance, safety and customer requirements are met. You will also provide... ...activities in the department are performed in accordance with GMP, relevant SOP’s and policies.
* Participate in management activities...
...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 / validation /...
...newest technician, you will ensure the highest quality and safety compliance standards while gaining exposure to new and advanced technology... ...out daily tasks as assigned by the Production Manager according to GMP and the quality system
~ Perform activities associated with the...
£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...
...marketing for consumer-driven product ideas.
Ensure regulatory compliance for global cosmetic standards.
Develop technical documents:... ...Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
~ Strong organizational skills.
~ Effective communication abilities...
...and budget delivery of Site Capital projects to be carried out in compliance with EHS and cGMP requirements. Projects include Building... ...Services.
* Drive and lead projects to meet Safety, Environmental, GMP, Production and Financial Objectives.
* Ensure compliance with all...
...supporting functions & areas of the site
Ensure cyber resiliency, compliance and data integrity regulatory standards are maintained and... ...similar
~9+ years relevant industry experience. Exposure to FDA, GMP, ISA95, safety and environmental legislation. Experience in the pharmaceutical...
...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 and for the...
...laboratory investigations where necessary.
-Support generation of GMP compliant SOPs, Protocols and reports
-Generate risk assessments... ...test items as required.
-Maintain Laboratory Data Integrity and compliance.
Profile and Requirements
The following are minimum...
...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...
...laboratory investigations where necessary.
Support generation of GMP compliant SOPs, Protocols and reports
Generate risk... ...test items as required.
Maintain Laboratory Data Integrity and compliance.
Profile and Requirements
The following are minimum requirements...
...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...
...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....
...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...
...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....
£43k - £51.6k per annum
...sheet reconciliations through Blackline.
* Drive process improvement initiatives to deliver on business objectives.
* Deliver full compliance with all regulatory requirements, including the support of external and internal audits.
* Variance Analysis - monthly management...
...group of EHS Professionals to develop and execute EHS plans, effectively supporting projects and engineering operations, and ensuring compliance and excellence in all aspects of EHS.
* Leading and overseeing key EHS Programs at the site, including but not limited to...