GMP Compliance and Validation Expert
4 days ago
About the Company
SK biotek Ireland, an SK pharmteco company, is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France, and Ireland. Our mission is to 'make what matters for a healthy, happier world', from grams to tonnes.
The Opportunity
We are seeking a QA Systems and Validation Specialist to join our team at the Swords Campus. This is a 12-month contract opportunity reporting directly to the Quality Manager.
Responsibilities
- Assess changes for GMP compliance in accordance with site change control procedures for facilities, utilities, lab, and manufacturing equipment and control system changes.
- Review and approve GMP design aspects of major capital projects, including new facility construction, facilities upgrade, new manufacturing equipment, and support systems.
- Ensure all quality systems are implemented and executed in compliance with ICH Q7, EudraLex, 21 CFR, and site quality standards.
- Provide expertise in validation ensuring compliance with current industry regulations, guidelines, and trends. Review master and completed qualification and validation protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
- Qualify premises, equipment, and utilities.
- Computer system qualification, CSV.
- Laboratory equipment validation.
- NPIs.
- High-level interaction with various functions on-site: Manufacturing, QC, Utilities, and Engineering.
Requirements
- A minimum of a BSc/BEng in Chemistry, Engineering, or a science-related discipline with at least 3 years of pharmaceutical experience ideally in a QA role. Preferably with experience in change control/documentation management, good manufacturing practices.
- Knowledge/appreciation of other site operations such as QC, Operations, Engineering, IT.
- Some experience in Operational Excellence or project management would be desirable.
- Knowledge of relevant regulatory requirements for Data Integrity, including GMPs.
-
GMP Compliance Specialist
4 hours ago
Dublin, Dublin City, Ireland VALIDATION ASSOCIATES LLC Full timeAbout Our ClientOleson is a specialist provider of consultancy and implementation services for IT infrastructure and data architectures within life science manufacturing. We take a full system view, understanding the complex relationships between manufacturing operations, business continuity, IT infrastructure, compliance & change control, and system...
-
GMP Compliance Expert
2 days ago
Dublin, Dublin City, Ireland Orion Group Full timeWe are seeking a GMP compliance expert to join our team at Orion Group. The successful candidate will have prior experience in a related field and be responsible for supporting the engineering department in maintaining a GMP compliant environment.The ideal candidate will be responsible for conducting root cause analyses, implementing corrective actions, and...
-
Validation Associate
8 hours ago
Dublin, Dublin City, Ireland VALIDATION ASSOCIATES LLC Full timeRole OverviewWe are seeking a highly skilled Validation Associate to join our team. As a key member of our technology strategy & transformation practice, you will play a crucial role in ensuring the quality and compliance of our clients' IT/OT systems.About UsOleson is a specialist provider of consultancy and implementation services for IT infrastructure and...
-
GMP Compliance Specialist
3 days ago
Dublin, Dublin City, Ireland Cpl Recruitment Full timeKey ResponsibilitiesThe QA Validation Lead will be responsible for: Qualification of computer systemsFamiliarity with ALCOA+ Data Integrity and Compliance AssuranceAssessment of changes for GMP compliance in accordance with site change control procedureLaboratory equipment validation and NPIsReview and approval of the GMP design aspects of major capital...
-
Validation Engineer
1 day ago
Dublin, Dublin City, Ireland Validation Associates Llc Full timeThe ultimate purpose of technology teams in GxP environments is to serve the evolving needs of the business.We are a specialist provider of consultancy and implementation services for IT infrastructure and data architectures within life science manufacturing.Our role is to be a companion on the road for technology teams to be able to use as a tool at times...
-
Validation Engineer
3 weeks ago
Dublin, Dublin City, Ireland VALIDATION ASSOCIATES LLC Full timeThe ultimate purpose of technology teams in GxP environments is to serve the evolving needs of the business. We are a specialist provider of consultancy and implementation services for IT infrastructure and data architectures within life science manufacturing. Our role is to be a companion on the road for technology teams to be able to use as a tool at times...
-
Pharmaceutical Validation Expert
8 hours ago
Dublin, Dublin City, Ireland DPS Group Global Full timeJob DescriptionWe are seeking a highly skilled Pharmaceutical Validation Expert to join our team at DPS Group Global. The successful candidate will be responsible for leading the validation of computer systems, ensuring compliance with regulatory requirements, and collaborating with various functions on site.Responsibilities:Qualify computer systems in...
-
GxP Validation Specialist
1 day ago
Dublin, Dublin City, Ireland Validation Associates Llc Full timeThe role of a Validation Engineer is pivotal in ensuring the seamless integration and operation of technology systems within GxP environments.At Validation Associates LLC, we are seeking a talented professional to join our team as a Validation Engineer.This position offers an exceptional opportunity to work with our blue-chip multinational clients within the...
-
Validation Lead Expert
3 days ago
Dublin, Dublin City, Ireland Cpl Recruitment Full timeJob OverviewCpl Recruitment, in partnership with SK pharmteco, seeks a highly skilled QA Validation Lead to join their team on a 12-month contract. The successful candidate will be responsible for ensuring the quality and compliance of our facilities, utilities, lab, and manufacturing equipment.The ideal candidate will have a strong background in validation,...
-
Validation and Compliance Expert
2 days ago
Dublin, Dublin City, Ireland eir evo talent Full timeJob Description: We are seeking a highly skilled Validation & CSV Lead Engineer to join our team. As a key member of our engineering department, you will be responsible for guiding the development of the master validation plan, creating validation strategies, and overseeing the creation of validation output documents. This role requires a deep understanding...
-
Validation Engineer
7 hours ago
Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full timeJob DescriptionWe are seeking a skilled Validation Engineer to join our team in Ireland. This role will involve working with our client, a major pharmaceutical company, to deliver a range of validation projects.
-
Lead Validator for Pharmaceutical Systems
8 hours ago
Dublin, Dublin City, Ireland DPS Group Global Full timeAbout the RoleWe are seeking a highly skilled professional to fill the position of Pharmaceutical Validation Expert at DPS Group Global. The successful candidate will be responsible for leading the validation of computer systems, ensuring compliance with regulatory requirements, and collaborating with various functions on site.Key Responsibilities:Validate...
-
GMP Manufacturing Process Expert
8 hours ago
Dublin, Dublin City, Ireland Planet Pharma Full timeJob SummaryWe are looking for a GMP Manufacturing Process Expert to join our team. In this role, you will work with both Fed-Batch and Continuous Manufacturing processes, collaborating with a dynamic team to ensure smooth and efficient operations.You will execute and support on-floor manufacturing activities, follow batch records, sampling plans, and SOPs,...
-
Quality Assurance and Validation Specialist
8 hours ago
Dublin, Dublin City, Ireland DPS Group Global Full timeJob SummaryWe are seeking a highly skilled professional to fill the position of Lead Validator for Pharmaceutical Systems at DPS Group Global. The successful candidate will be responsible for leading the validation of computer systems, ensuring compliance with regulatory requirements, and collaborating with various functions on site.Main...
-
GMP Manufacturing Process Expert
2 days ago
Dublin, Dublin City, Ireland Discover International Full timeWe're currently seeking a highly skilled GMP Manufacturing Process Expert to join our team on a 12-month contract in Dublin, Ireland.About the TeamThe ideal candidate will have a minimum of 5 years' experience in GMP manufacturing within a pharmaceutical environment and a strong understanding of regulatory environments and pharmaceutical manufacturing...
-
GMP Compliance Officer
2 days ago
Dublin, Dublin City, Ireland Grifols, S.A Full timeKey ResponsibilitiesCommunication: Daily briefing on Quality batch review/approval, providing quality performance information as required, ensuring regular Quality interaction with other Departments.Quality Release Activities: Quality batch documentation review and control, Quality in-process control including vial defect inspection, Quality visual...
-
QA Validation Lead
1 week ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeQA Validation Lead at SK pharmtecoLocation: Swords, Co DublinContract: 12 monthsABOUT USSK pharmteco is a global Contract Development and Manufacturing Organisation (CDMO) with state-of-the-art facilities in Korea, US, France, and Ireland. We are part of SK Inc., a Korea company with revenues of $99 billion in 2023. Our mission is to 'produce and deliver...
-
QA Validation Lead New
4 weeks ago
Dublin, Dublin City, Ireland CPL Full timeCpl in partnership with The SK pharmteco Small Molecule facility located in Swords, Co Dublin, are looking for a QA Validation Lead to join the team on a 12 month contract.ABOUT US?SK pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part of SK Inc., a...
-
Pharmaceutical Validation Expert
2 days ago
Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time**Role Overview:**Quanta Consultancy Services Ltd is looking for a talented Validation Engineer to join their team.Job Responsibilities:The successful candidate will be responsible for ensuring that all equipment and processes meet regulatory requirements.This includes designing, implementing, and maintaining validation protocols and procedures.Key...
-
Validation Lead
8 hours ago
Dublin, Dublin City, Ireland DPS Group Global Full timeCompany OverviewDPS Group Global is a leading organization in the field of pharmaceutical development and manufacturing. We are committed to delivering high-quality products and services to our clients, while maintaining the highest standards of safety, efficacy, and compliance.Job Description:We are seeking a highly skilled Lead Validator for Pharmaceutical...