Search Results: 17 vacancies
...CD Applications and Reconciliations
Assisting the RP/DRP with the process of returns
Reporting of Exempt Medicinal Products to HPRA
Assisting with Recalls process
Customer/Vendor/Product Setup approvals
Bona Fides: Assisting with carrying out checks on both...
...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...
...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...
€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...
....
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...
...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...
...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...
...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...
...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...
...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...
...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...
...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,...
...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...
...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...
...Manage incoming delivery scheduling from internal and external suppliers.
Reporting of the receipt of Exempt Medicinal Products to HPRA.
Raw material ordering and liaising with suppliers.
Handling of quality/warehouse issues.
Contributing to Production/...
...Chemistry/ Health Sciences fields.
- 1 - 3 years’ experience in pharmaceutical QC environment or equivalent
- Experience working in an HPRA/FDA regulated environment is essential
- Knowledge and hands-on experience in Analytical Chemistry, and QC procedures.
- Result...
...manufacturing required
Direct experience of GMP management within a pharma/biopharma company is essential, including exposure to FDA, HPRA or other authorities of similar standing
Excellent accuracy and attention to detail
Good knowledge of relevant computer packages...