...Approve product labels, package inserts and Marketing material.
Create and maintain audit friendly product file for customers and HPRA assurance. A reliable & compliant supply chain is essential to the future of our expansion and our current business trading.
A key element...
Collins McNicholas Recruitment
Leinster
1 day ago
...targets.
Provide practical and pragmatic solutions to any issues encountered.
Work closely with Regulatory and be capable of hosting HPRA and any other audits.
Requirements:
~ A 3rd level qualification in a relevant science or Quality discipline
~3-4 years working...
Collins McNicholas Recruitment
Leinster
3 days ago
...interfaces and collaborates with corporate and other site management in assuring that AbbVie Ireland Clonshaugh is fully compliant with HPRA, FDA and corporate standards. The Associate Director is responsible for transitioning developmental products into AbbVie Ireland...
...quality management systems such as Veeva SAP PASX Delta V Trackwise etc.
~ Knowledge of industrial regulations including those of FDA HPRA EMEA and other authorities related to Biologics and/or Pharmaceuticals.
Desirable:
Experience in direct interactions with...
...current cGxP.
Ensuring the quality management system is operating as efficiently and effectively as possible and is compliant with HPRA requirements.
Assessing CMO customer requirements and ensuring that these are met.
Determining raw material and finished goods testing...
...independently.
~ Familiarity with quality management systems such as Veeva, SAP, PAS-X, Delta V, Trackwise, etc.
~ Knowledge of FDA, HPRA, EMEA, and other regulatory requirements related to Biologics and/or Pharmaceuticals.
Desirable Skills:
Experience in direct...
Life Science Recruitment
Leinster
2 days ago
€50k per annum
...Manage Incoming delivery scheduling from internal and external suppliers.
Reporting of the receipt of Exempt Medicinal Products to HPRA.
Raw Material Ordering & Liaising with Suppliers.
Handling of Quality/Warehouse Issues.
Contributing to Production/Planning Calls...
Bespoke Recruitment Limited
Dublin
1 day ago
...WDA, MIA, ASR)
Ensure processes are maintained in support of BLIL as MAH
Manage communications with and represent BLIL in front of HPRA.
Provide QA expertise to BLIL and manage any Quality issues that arise to closure.
Support HPRA inspections of BLIL and prepare...
Bausch & Lomb GmbH
Dublin
1 day ago
....
Perform to weekly/monthly KPI measured internal and external business demands.
Manage AEO site process requirements.
Manage HPRA / GDP site process requirements as an operations manager.
Support and work closely with the Facilities Manager to ensure the site is...
Broadline Recruitment Group Ltd.
Dublin
2 days 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
23 hours ago
...working laboratory.
To highlight and where necessary implement new technologies in QC area.
Preparing for and support external audits (HPRA, FDA, corporate, client).
Ensure data integrity guidelines are implemented and adhered to for QC based systems.
General...
Takeda
Dublin
4 days ago
...requirements in all clinical research activities.
Assist in the preparation of studies/trials for audit, including internal, sponsor, and HPRA audits.
Work with Trial Coordinators on trial-specific activities, including patient interaction in clinics.
Maintain...
TTM Healthcare Limited
Dublin
1 day ago
...laboratory-testing environment within the biological and/or pharmaceutical industry.
Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory
Good knowledge of LIMS, Trackwise and Electronic documentation systems.
Good knowledge of Microsoft Office...
PE Global (UK)
Dublin
2 days ago
...Quality groups.
Manage and maintain robust relationships with the Viatris internal leadership team, industry colleagues and with the HPRA & FDA organisations.
About Your Skills & Experience
For this role, we’re looking for a candidate who has an effective combination...
Viatris
Dublin
3 days ago
...medicines licensed in Ireland and proactively keep this up to date.
Builds strong relationships with the Regulatory Agencies (e.g. HPRA, FSAI and PSI) to ensure that Boots is operating in line with current legislation.
Responding to Regulator public consultations relating...
The Boots Company PLC
Dublin
9 hours agonew
...management systems such as Veeva, SAP, PAS-X, Delta V, Trackwise etc.
• Knowledge of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.
• Direct experience in interacting with regulatory agencies...
Asset Recruitment
Dunboyne, Co. Meath
1 day ago
...Quality groups.
Manage and maintain robust relationships with the Viatris internal leadership team, industry colleagues and with the HPRA & FDA organisations.
About Your Skills & Experience
For this role, we’re looking for a candidate who has an effective combination...
Viatris Company
Dublin
3 days ago
...Develop clients understanding and fulfilment of regulations including:
Joint Commission International (JCI)
CHKS
HIQA
ISO
HPRA
National and International Best Practice
Develop and educate re process control and the use of Policies & Procedures Framework,...
Hci
Dublin
1 day ago
...escalation & follow up for effective resolution to minimise impact on the manufacturing schedule.
Contribute and assist with corporate, FDA, HPRA and other regulatory bodies during company audits .
Takes the lead on the 24/7 shift team in the absence of the Manufacturing...
Amgen Inc. (IR)
Dublin
2 days ago
...approvals have been adhered to and are in place prior to the commencement of all research projects.
Prepare for Internal / Sponsor / HPRA audits as required.
Liaise with patients and their relatives (if appropriate) to inform them on the proposed research and standard...
Royal College of Surgeons in Ireland
Dublin
3 days ago
...through to closure, in conjunction with the company’s Global Complaints Departments and in accordance with all relevant EU legislation, HPRA Guidelines and company specific Standard Operating Procedures.
· The administration, preparation, issue, and control of documents in...
Cpl Healthcare
Dublin
2 days ago
...Quality groups.
Manage and maintain robust relationships with the Viatris internal leadership team, industry colleagues and with the HPRA & FDA organisations.
About Your Skills & Experience
For this role, we’re looking for a candidate who has an effective combination...
Viatris Inc.
Dublin
3 days ago
Senior Principle Scientist , Sterile Drug Product Aseptic Process (Manufacturing, Science & Tec[...]
...Aseptic Training, 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...
Bristol-Myers Squibb
Dublin
3 days ago
...quality plans and continuous improvement programmes within the department and in other.
Prepare for and supporting external audits (HPRA, FDA, corporate, or client).
Implement and maintain standards of safety to guarantee a safe working laboratory. Ensure that the laboratory...
Takeda
Bray, Co. Wicklow
1 day ago
...Pharmaceutical or Biopharmaceutical company, ideally with experience in both upstream and downstream processing.
Good knowledge of GMP/HPRA/FDA regulatory requirements.
Strong technical writing skills.
Self-starter with strong communication, problem-solving and...
AstraZeneca GmbH
Dublin
2 days ago
..., root cause analysis and Corrective/Preventative Action generation.
Participate in and support audits, both internal and external (HPRA/FDA etc.) Act as the primary point of contact for audit discussions relating to sample management.
Build and foster strong relationships...
Bristol-Myers Squibb
Dublin
2 days ago