GMP Inspector

ROLE SUMMARY Reporting to a Senior Inspector, the Inspector will be primarily responsible for assessing the compliance of manufacturers with EU Good Manufacturing Practice (GMP). The role of an Inspector is to evaluate the compliance of sites inspected, in Ireland and abroad, with the requirements of National legislation (in Ireland), European Community Directives, Regulations and Guidance. These sites may include; o Manufacturers and distributors of medicinal products. o Manufacturers of investigational medicinal products. o Sites involved in the storage of medicina...

Location: Dublin,

Medical Information Analyst Fluent Danish

Medical Information Analyst Fluent Danish Our client, a global pharmaceutical organisation based in Cork are currently recruiting for a Medical Information Analyst. Fluency in Danish and English is essential. As Medical Information Analyst you will professionally responding to medical/pharmaceutical inquiries from Health Care Providers (HCP), patients and other customers. You will also be responsible for documenting all customer interactions in the appropriate computer system. Responsibilities Handle calls requesting product information from HCPs and the general pub...

Location: Cork,

Senior Associate QC

We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Dublin This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties This job specification outlines the general responsibilities associated with the role of QC Senior Associate for the Imlygic laboratory on the Manufacturing site. This role will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to lab operations and compliance,...

Location: Dublin,

Business Development Manager (Hospitals - Eyecare)

Our client is a leading Healthcare Company, based in Dublin. They are seeking an experienced Business Development Manager with strong secondary care sales & account management experience. This role involves representing our client as a sales and business development professional within a defined geographical area. The role involves acting as a point of contact on a local level for the customers in their varying roles in Leinster Hospitals and maximising service-orientated contact with the ophthalmology consultants. This is principally a Secondary care role but occasion...

Location: Dublin,

Quality Engineer

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties Main duties and responsibilities: • Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. • Collaborates with engineering and manufacturing functions to ensure qual...

Location: Galway,

Clinical Regulatory Associate

Clinical Regulatory Associate Our client, a global pharma company are currently recruiting for a Clinical Regulatory Associate to join their team on a permane

Location: Cork,

Regulatory Associate CMC (LO A008365)

The Global Regulatory Affairs group islooking for an associate to lead and partner with Chemistry, Manufacturing and Controls (CMC) Regulatory Scientists in the various aspects of global marketing authorization submission management processes. This exciting opportunity will enable you to utilize your project management and communication skills to advance the submission process for new molecules. You will also partner with CMC Scientists to help build and manage submission content, provide guidance on structure and content placement within Common Technic...

Location: Cork,

Packaging Technologist (LO A008354)

The Packaging Technologist will work directly with the Production, Quality, and Innovation teams, focusing on design, construction, and material usage for the product range. They will work to improve the industrial techniques used to package our products and drive internal packaging processes to minimize waste and improve efficiencies. Role Deliverables Packaging Development: Manages packaging development and improvement projects to meet business needs Developing knowledge of packaging materials and the related production processes...

Location: Louth,

Senior Director, Clinical Research

Senior Director, Clinical Research Our client is a global Biopharma with leading therapies in infectious diseases & oncology in particular. They are establishing a Centre of Excellence in Dublin for their global Paediatric Trials. The Sr Director MD, Clinical Research, position will design, conduct, and evaluate Phase 1, 2, and 3 clinical trials and provide scientific expertise on paediatric viral infectious diseases. They are seeking a qualified Medical doctor with extensive clinical trials experience gained in industry. Infectious diesase & paediatrics exp...

Location: Dublin,

Clinical Project Manager

Clinical Project Manager Our client biopharmaceutical organisation is recruiting for a Clinical Project Manager to join their team. As Clinical Project Manager you will coordinate the day-to-day management of the clinical operations activities of the organisation. Remote working with the ability to be in the Dublin office bi monthy is an option for this role. Responsibilities Provides direction to the Clinical Development Team (CDT) Develop and maintain effective working relationships with other CDT members Ensures that each CDT member is aware of his/her specific area ...

Location: Republic of Ireland,

Director of Clinical Pharmacology (Infectious Diseases)

Our client is a leading Bio-Pharma who are establishing a new office in Dublin in the area of Clinical Research, with specific focus on Pediatric Trials. As a Director within the Clinical Pharmacology Group, the successful person will have ultimate responsibility and accountability for clinical pharmacology programs in the area of HIV and emerging viral infections. As a member of the Clinical Pharmacology team this person shall have unparalleled opportunity to be involved with every aspect of the product development process, from first-in human through approval, including ...

Location: Dublin,

Manager/Senior Manager QA Operations

Manager/Senior Manager QA Operations Our client, a growing Biopharma organisation are currently recruiting for a Manager/Senior Manager QA Operations to join their team on permanent basis. As Manager/Senior Manager QA Operations you will beresponsible for overseeing a QA team and their projects. Responsibilities Responsible for all aspects of QA Team including review and approval of the following types of documents, relating to area functions; Master records, executed records, failure investigations Change Controls, SOPs, Validation protocols and summary re...

Location: Limerick,

QC Technical Specialist (LOA008304)

POSITION OVERVIEW Reporting to the Quality Control Lab, Systems and Compliance Team Leader, this position will have a significant role in the automation of analytical methods using SmartLab. This includes coordinating with the Quality Control Lab, writing SmartLab script, performing demoes, troubleshooting and verification of other Scripters work. A candidate experienced in Waters Empower administration would also be involved in the administration of same and connection of new instrumentation. QC TECHNICAL SPECIALIST RESPONSIBILITIES: Write SmartLab sc...

Location: Cork,

Quality and Regulatory Affairs Manager

Quality & Regulatory Affairs Manager Our client, a leading healthcare organisation are currently recruiting for a Quality and Regulatory Affairs Manager to join their team on a permanent basis. As Quality & Regulatory Affairs Manager you will be responsible for leading the regulatory affairs and quality assurance functions within the organisation. You will manage the department effectively to ensure compliance, continuous improvement and to ensure product quality and customer satisfaction. Responsibilities Provide Quality & Regulatory ...

Location: Dublin,

Snr Associate QC Microbiology

We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties • Endotoxin testing of water, in-process and drug product release samples • Bioburden testing of water & in-process drug product sample • Sterility testing • Water sampling • Lab Support duties such as Biological Indicator testing, Growth Promotion, Me...

Location: Dublin,

Clinical Trial Start Up Associate Fluent Romanian

Clinical Trial Start Up Associate- Fluent Romanian Our client, a global pharmaceutical organisation are currently recruiting for a Fluent Romanian speaking Clinical Trials Start Up Associate to join their team on a permanent basis. As Clinical Trial Start Up Associate you will be responsible for ensuring the investigator sites meet requirements to enrol study participants into clinical trials and support ongoing activities during site maintenance and closeout, obtaining clinical trial authorizations and ethical approvals,execution of the budget and contract, and activiti...

Location: Cork,

Sr Quality Engineer

We’re currently recruiting for an exciting opportunity with an award-winning medical Device organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties Responsibilities may include the following and other duties may be assigned. • Undertakes and successfully completes complex test method development tasks including: creation, writing, test method validation, equipment qualification and supporting on-going maintenance of test methods. • Leads ...

Location: Galway,

Snr Associate QC

We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties Testing of raw materials, in process, stability and finished product samples. Eg Ph, Appearance, Colour, Clarity, Sub Visible Particle testing, Osmolality, Protein Concentration, Polysorbate, Moisture and Device testing. Review and authorisation of Lab Data Support Analyt...

Location: Dublin,

Senior CMC Project Manager

Senior CMC Project Manager Our client, a biopharmaceutical organisation based in Dublin, are currently recruiting for a Senior CMC Project Manager to join their team on a permanent basis. As Senior CMC Project Manager you will be responsible for the coordination of and the day-to-day management of CMC projects. Responsibilities Develop and execute the strategy for development and clinical study production of the organisations drug products in alignment with company goals and clinical plans Oversee all CMC activities with vendors, relating to both drug substance, drug ...

Location: Dublin,

Quality Operations Senior Specialist (LOA008170)

The Role This Pharmaceutical company is looking to recruit a Quality Operations Senior Specialist, Drug Product, EMEA and Asia Pacific on a 12 month fixed-term contract (maternity cover)to provide quality and compliance oversight support to the Quality Operations management team within External Manufacturing . Key Duties and Responsibilities: Support the coordination of quality events, change control and market complaints programs in respect of Third Party Manufacturer and Alliance Partnership relationships. Actively support the Fac...

Location: Dublin,

QA Validation Manager LO(A008122)

Summary: This position implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards, and oversees a team of Validation Specialists. This position will specifically be accountable for Continuing Validation/Qualification for Laboratory, Facilities and Equipment. This company have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centres and stock for employees at all levels! Essential Duties...

Location: Limerick,

Senior QA Validation Specialist - Cleaning Validation

A Senior QA Validation Specialist – Cleaning Validation is required to join a rapidly expanding Biopharmaceutical organisation in Limerick. The key focus of the role is to schedule, execute and review Continuing Qualification activities for large and small equipment in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures The role Assess executed change controls and deviations for impact to the Qualified state for conformance to regulations, SOPs, specifications and other applicable ac...

Location: Limerick,

Process Scientist-Associate Manager LO(A008014)

Summary: Lead a team to manage all activities to ensure that manufacturing processes are supported. Responsible to support the Process Sciences Department through Process Validation, manufacturing floor support, product impact assessments, investigations, and technical evaluation as required. Active member of the Process Sciences management team. Essential Duties and Responsibilities include, but are not limited to, the following: • Lead a team and manage all activities to assure that manufacturing processes are supported. • Responsible fo...

Location: Limerick,

Senior Validation Engineer

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties Validation oversight of External Manufacturing sites (API, DS/DP), including process, cleaning, filter and sterilization/sanitization validation activities. • Validation document author/approver • Ensure validated parameters are correctly incorporated in Master Batch Records &bul...

Location: Dublin,

Internal Product Specialist (Chemistry)

Our client is a leading supplier of laboratory chemicals, standards, reagents, consumables and instrumentation across many sectors in Ireland. Theyspecialise in equipment & consumables for R&D, life sciences, quality control, process measurement & environmental monitoring across the Pharmaceutical, Medical Devices research, Food and Beverage, Chemical industries and Education Sectors. They are currently seeking an Chemical Specialist who will work alongside their clients to provide solutions to their requirements. 1+ years previous inter...

Location: Dublin,

Clinical Trials Project Manager

Clinical Trials Project Manager Our client, a global pharmaceutical organisation based in Cork are currently recruiting for a Clinical Trials Project Manager to join their newly created team on a permanent basis. As Clinical Trial Project Manager you will lead the cross-functional study team in the development and execution of clinical trials and will be responsible both regionally and globally to deliver trials with quality, on time, and within scope and budget. Responsibilities Use project management skills, processes and tools to develop and execute loca...

Location: Cork, Republic of Ireland,

QC Manager-Technical Resources (LO A007957)

Summary: Perform, review and manage assay development, characterization, optimization, transfer, validation and investigation for QC chemistry or QC Biochemistry group. Provide technical support, guidance and supervision for release, stability, and in-process testing and assay development. Essential Duties and Responsibilities include, but are not limited to, the following: • Perform, review and manage assay development/validation for QC Chemistry or QC Biochemistry group. • Review new test procedures and assays. • Ma...

Location: Limerick,

Senior QA Specialist

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties •Provide high complexity tactical support to Site Leads across multiple Quality Systems and Processes. • Manage and own NC records for External Quality • Manage and own CAPA records for External Quality • Manage and own Change Control records internal to External Qualit...

Location: Dublin,

Senior R&D Engineer

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties Seeking an experienced engineer to focus on all stages of the product development process from concept generation through to commercializing of cutting-edge structural heart devices. This is an exciting opportunity to get involved in the rapidly growing world of Structural Heart. The role includes the fol...

Location: Galway,

Director, Quality & Compliance (GCP)

Our client is a global Biopharma organisation who play a crucial role in developing life-saving therapies. They are seeking a Clinical Quality and Compliance Director who is ready to dive-in to support our clients clinical development programs. As a Clinical Quality and Compliance Director, you will support and work with our clinical study management teams and teammates across R&D Quality and Compliance. They need someone with strong leadership skills, expert Good Clinical Practice (GCP) knowledge, audit skills, communication, facilitation skills, and the ability to...

Location: Dublin,

LIMS Developer (LOA007780)

Role Summary The LIMS Developer will perform configuration, development, and validation activities to support LabWare LIMS enhancements. The ability to configure and program in LabWare LIMS is required. Role Responsibilities: • Develop and implement improvements • Propose technical solutions and architectures • Support validation activities • Develop Functional Requirements and Configuration Specifications • Manage iterative development of system as needed to ensure system meets business needs • Work closely with CSV ...

Location: Cork,

Clinical Trial Associate German Speaking (based in Ireland)

Clinical Trial Associate German Speaking (based in Ireland) Our Cork based client are currently recruiting for an experienced fluent German speaking Clinical Trial Associate to join their team on a permanent basis. The Clinical Trial Capabilities Team provides clinical trial capabilities in support of clinical development. As Clinical Trials Associate you will be accountable to ensure the investigator sites meet requirements to enrol study participants into clinical trials and support ongoing activities during site maintenance and closeout. You will be responsible for obtaining clini...

Location: Cork,

Clinical Trial Associate German Speaking (based in Ireland)

Clinical Trial Associate German Speaking (based in Ireland) Our Cork based client are currently recruiting for an experienced fluent German speaking Clinical

Location: Cork,

Process Scientist-Manufacturing Support Process Validation (LOA006903)

Summary: Supports the Manufacturing Support Process Sciences Department with analysis, troubleshooting, and Process Validation of manufacturing bioprocesses. Essential Duties and Responsibilities may include, but are not limited to, the following: • Supports all Process Validation activities • Define Process Validation Strategies • Author, review and approve Process Validation protocols and reports • Schedule and support Process Validation executions • High level of technical and scientific writing required &...

Location: Limerick,