2 Gmp Compliance jobs in Ireland

QC Validation Specialist

Shannon, Munster Hobson Prior International Ltd

Posted 4 days ago

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Job Description

Overview

Skilled and dedicated in engineering? Looking for a new challenge in Validation? Proclinical is seeking a QC Validation Specialist which is your next perfect role!

This position will be required to lead the validation of test methods and ensure full compliance with EU and FDA GMP standards while contributing to the development of cutting-edge analytical techniques.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities
  • Help develop and validate new and existing test methods for gene therapy products.
  • Create and analyse protocols, reports, and data to support method transfer activities.
  • Ensure all methods meet regulatory standards and maintain data integrity.
  • Write and update standard operating procedures (SOPs) for validated methods.
  • Communicate progress and updates on method transfers to stakeholders.
  • Regularly review analytical methods to ensure they are functioning as expected.
  • Support the maintenance of the Quality Management System and document control processes.
  • Track and achieve personal goals and timelines effectively.
  • Perform testing of gene therapy products when required, ensuring alignment with production schedules.
Key Skills and Requirements
  • Background in human health or sciences, with relevant qualifications.
  • Experience in quality control or analytical method validation in a regulated industry.
  • Familiarity with techniques such as qPCR, HPLC, ELISA, Western blot, cell culture, and DNA extraction.
  • Knowledge of ICH Q2 R1 guidelines and proficiency in Microsoft Office tools.
  • Strong organizational and communication skills.

For more information, please contact Grant Van Schalkwyk.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data -

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Principal Regulatory Compliance Specialist

Dublin, Leinster Oracle

Posted 12 days ago

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Job Description

**Job Description**
Oracle Cloud Infrastructure (OCI) is seeking a highly skilled and detail-oriented Regulatory Compliance Specialist to join our dynamic team. As a key player in our global organization, you will be responsible for managing audits and assessments, and informing OCI on regulatory changes so that we maintain a high level of compliance and adhere to all relevant regulations, policies, and standards.
We are looking for a Regulatory Compliance Specialist who is looking to grow their career in Cloud. You will be responsible for the support and implementation of scalable audit programs to support Oracle Cloud Infrastructure's growth in regulated markets within the Europe, Middle East, and Africa (EMEA) region with a specific focus on Europe.
The ideal candidate will have the following skills:
· 8+ years audit program management experience with either a "Big 4" accounting firm, or a mid-level accounting firm.
· 4+ years proven experience as a Regulatory Compliance Specialist or similar role.
· Knowledge of industry and regulatory frameworks is preferable, such as ISO 27000 Series, SOC 1, SOC2, ENS, ACN, Cyber Essentials+, EU CoC, TISAX, etc.
· Strong analytical and problem-solving skills.
· Excellent communication and interpersonal abilities.
· Ability to work collaboratively with cross-functional teams.
· Possess ability to explain complex auditing topics to audiences with no auditing experience.
· Ability to prioritize, manage, and deliver on multiple projects simultaneously and partner with management in support of key initiatives and projects.
· Strong bias toward action, flexible, resourceful, and able to operate effectively within a dynamic, fast-paced environment.
· Superior communication skills (interpersonal, verbal, presentation written, email, tickets, etc.)
Preferred Qualifications:
· JIRA and Confluence experience strongly preferred.
· Professional certification in regulatory compliance (i.e. PMP, PgMP, CISA, CISM, CISSP, CIPP)
#LI-DNI
**Responsibilities**
Responsibilities:
Manage Audits and Assessments:
· Plan, manage, and conduct regular compliance audits with third party auditors.
· Communicate OCI processes and policy to third party auditors effectively.
· Report findings and recommend corrective actions as needed across different stakeholder groups.
· Foster a culture of compliance awareness through regular communication and educational initiatives.
· Effectively communicate in remote working environment over video, phone, email and other tools.
Stay Informed on Regulatory Changes:
· Monitor and stay up-to-date on changes to local, national, and international regulations affecting cloud service providers in EMEA, specifically within Europe.
· Analyze the impact of regulatory changes and provide recommendations to the management team.
· Conduct regular reviews and updates of existing policies to ensure ongoing relevance.
Regulatory Reporting:
· Prepare and submit timely and accurate regulatory reports to relevant authorities in accordance with applicable regulations.
· Work closely with internal teams to gather necessary data and information for reporting purposes.
· Provide clear expectations and direction to security and engineering teams within OCI on audit requirements.
Career Level - IC4
**About Us**
As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity.
We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all.
Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.
We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing or by calling in the United States.
Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
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