Search Results: 51 vacancies
...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
2 days 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
2 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
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
5 days ago
...or EQ Account owners for CMOs
· Will partake in the Vaccine program Janssen Q&C initiatives at the ECLs
· Apply cGMP regulations, FDA and international requirements to all aspects of the position.
· Ensure timely and proper reporting to partners and stakeholders...
Johnson & Johnson
Cork
3 days ago
...qualification activities
Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and HPRA).
Provide key support and technical expertise to the site to ensure people and technical skills are in place to implement...
Collins McNicholas Recruitment
Cork
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
2 days ago
...laboratory-testing environment within the biological and/or pharmaceutical industry.
* Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory.
* SPECIFIC TESTING EXPERIENCE REQUIRED: Initiation and Maintenance of Mammalian Cell Lines,
Cell...
Fastnet - The Talent Group
Cork
1 day ago
...both PC and MAC platforms, proficient in MS Office, and adept with graphic design software.
Possesses comprehensive understanding of FDA cGMP standards and regulatory guidance materials.
Specific education and experience requirements:
Relevant professional...
Gilead Sciences, Inc.
Cork
1 day ago
...Quality/Regulatory Affairs environment or6 years Microbiology related experience.
Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
Must possess effective communication, project management and influencing skills as well as have the...
Stryker Group
Cork
3 days ago
...key member of JSC Global Quality Leadership Team.
Ensures all employees comply with all applicable JSC and governmental (EPA, HSA, FDA, etc.) regulations, policies and guidelines.
Management Representitive (MR) of Quality Systems Management Review (QSMR).
Other...
Johnson & Johnson
Cork
2 days ago
...Demonstrated Project Management experience in Product Transfer and/or New Product Introduction in a regulated environment
Experience in an FDA regulated or regulated industry
Experience of process/ product validations, statistical methods, GD&T, Process mapping,...
Stryker Group
Cork
2 days ago
...Regulatory Scientist in the development of regulatory strategy by leveraging scientific, drug/device clinical development and knowledge from FDA/Health Canada meetings and regulatory trends. Integrate information from the external environment, product specific regulator advice,...
Eli Lilly and Company
Cork
2 days ago
...manufacturing and supply chain management experience
• Multi-Site Manufacturing Leadership experience Require
• Strong understanding of FDA Quality System Requirements and related global Medical Device Quality Standards
• LEAN manufacturing and quality management expertise...
Toms Gruppen A/S
Cork
3 days ago
...effective communication and influence with internal Lilly customers (e.g. medical, regulatory, labeling) and external stakeholders (e.g. FDA, MHRA, EMA, other regulatory agencies)
Accelerate the advancement of and contribute to the development and coaching of peers and less...
Eli Lilly and Company
Cork
5 days ago
...Qualifications and experience
• A third level qualification of a scientific/technical discipline is required.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC...
Kenny-Whelan & Associates
Ringaskiddy, Co. Cork
4 days 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
3 days ago
...A competitive basic salary + shift allowances and benefits package provided!
About the company:
Our Fermoy, Ireland, facility is FDA registered and certified to ISO 13485 for the manufacture of high-quality PCBAs, subassemblies and complete devices up to and including...
Sanmina Corporation
Fermoy, Co. Cork
4 days ago
...~ Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams
~ Experience in an FDA regulated, or regulated industry beneficial
About Stryker Stryker is a global leader in medical technologies and, together with its...
Stryker Group
Cork
3 days ago
...and facilitation skills.
· Advanced PC skills such as Excel, Word, PowerPoint.
· Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.
· Experience in a FDA / HPRA Regulated production environment.
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PSC Biotech
Cork
4 days ago
