Search Results: 295 vacancies
...years’ experience in a QC Analyst role.
~ Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines
PHYSICAL DEMANDS: Health & Safety requirements (eg. Manual Handling Training)
To take reasonable care for their own...
Chanelle Group
Galway
20 hours ago
...Experience and Skills:
Preferred:
At least 3 years’ experience or related post graduate academic experience.
Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
Knowledgeable of stability data trending and protein stability...
Johnson & Johnson
Cork
3 days ago
...certification to all regulatory bodies. Plays a lead role in all internal and external audit programmes such as Corporate, notified body & FDA audits.
Ensures effective control of product/process deviations for all released product and for the implementation of effective...
Stryker Group
Limerick
20 hours ago
...experience in a quality, manufacturing, validation or compliance role within the pharmaceutical industry.
· Experience & Knowledge of FDA/HPRA / EMEA regulatory requirements applicable to pharmaceuticals. Ability to apply GMP regulations and other FDA and international...
Johnson & Johnson
Cork
4 days ago
...complex technical information to upper level management.
Minimum 5 years
Experience in dealing with regulatory authorities such as FDA.
Managerial/leadership experience
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Abbott Laboratories
Ireland
20 hours ago
...experience and educational background that may otherwise satisfy the other requirements of the role.
Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems.
Demonstrated ability to work independently and fully realize improvement initiatives...
BIOMARIN
Cork
3 days ago
...appropriately archived or disposed of.
Ensure that all quality-related documents adhere to relevant regulatory requirements, such as FDA regulations, ISO standards, and industry best practices.
Provide support for the development, implementation, and maintenance of the...
Wallace Myers International
Galway
2 days ago
...Kaizen events.
Generate and maintain appropriate records and data to ensure compliance with company policies & procedures as well as FDA QSR and ISO requirements.
The Essential Requirements Of The Job Include
~ Degree level preferably with localization background....
Localizationacademy
Ireland
4 days ago
...required.
Candidates will have worked on automation systems in cGMP regulated manufacturing environments and be knowledgeable regarding FDA cGxP and 21 CFR Part 11 regulations, and understand software system validation in this context, is desired.
Experience with Siemens...
Gilead Sciences, Inc.
Cork
4 days ago
...provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard:
Our approach is simple; we put the client’s interests...
Cagents
Ireland
1 day ago
...department files.
Demonstrates commitment to the development, implementation and effectiveness of the Quality Management System per ISO, FDA, and other regulatory agencies.
Responsible for exhibiting professional behavior with both internal/external business associates...
Collins McNicholas Recruitment
Galway
3 days ago
...the biological and/or pharmaceutical industry.
· Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or... ...industry regulations as they apply to quality, including those of FDA, IMB, EMEA and other authorities.
DESIRABLE:
· Experience in auditing...
Kenny-Whelan & Associates
Ringaskiddy, Co. Cork
1 day ago
Senior Principle Scientist , Sterile Drug Product Aseptic Process (Manufacturing, Science & Tec[...]
...and Qualification programs within the new Sterile Drug Product facility.
Participates in Health Authority inspections (HPRA, EMEA, FDA, and International Authorities) which includes managing the requests and responses, providing updates, and adherence to the regulatory...
Bristol-Myers Squibb
Dublin
4 days ago
...quality assurance within a biotechnology or pharmaceutical manufacturing environment.
Strong understanding and working knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.
Demonstrated proficiency in planning...
Eli Lilly and Company
Munster
2 days ago
...assisting in implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA 21CFR Part 820 as required and other jurisdictions as required.
Maintains an excellent understanding of the global medical device...
Cook Medical Incorporated
Limerick
20 hours ago
...IR, UV, dissolution & physical testing.
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 "Apply"...
Hobson Prior International Ltd
Connacht
1 day ago
...a pharmaceutical, biotechnology, CRO or other health care setting
~ Knowledge of imaging guidelines for clinical trials, such as the FDA “Clinical Trial Imaging Endpoint Process Standards Guidance for Industry”
~ Strong written and verbal interpersonal skills
~ Ability...
ICON
Dublin
4 days ago
...site change control, risk management and data integrity initiatives/programs.
Strong knowledge and understanding of EU annex 11 and FDA 21 CFR Part 11.
Previous experience as SME in highly regulated environment (e.g. pharma, biotech, medical devices) in both internal...
Regeneron Pharmaceuticals, Inc
Munster
1 day ago
...laboratory.
To highlight and where necessary implement new technologies in QC area.
Preparing for and supporting external audits (HPRA, FDA, corporate, client).
Ensure data integrity guidelines are implemented and adhered to for QC based systems.
General...
Takeda
Dublin
1 day ago
...Education and Experience/Competencies:
A third level qualification of a scientific/technical discipline is required.
Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
Builds strong productive relationships.
Demonstrates...
Orion Group
Cork
1 day ago
