Search Results: 55 vacancies
£38.7k - £47.3k per annum
...in our current markets and
liaise with non-compliant potential suppliers.
* Maintain audit ready product database for customers and HPRA assurance.
* Maintain organized and up-to-date regulatory files, records, and documentation, ensuring
accessibility and accuracy for...
Ireland
12 hours agonew
...expected to work on their own initiative.
* Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines.
* Individual is fully responsible for the co-ordination and closure...
Sligo, Co. Sligo
8 days ago
£25.8k - £30.1k per annum
...knowledge of aseptic processes' manipulation together with experience within a GLP/GMP environment and knowledge of current EU/FDA/ICH/HPRA guidelines.
* Lab experience within industry - Bioburden / Endotoxin / Growth Promotion / Environmental Monitoring.
* Experience within...
Ireland
14 days ago
...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...
...Process/ Chemical Engineering discipline.
~5+ years experience in batch processing, automation, commissioning and validation in an FDA/HPRA regulated industry.
~ Background as a technical leader in either a process engineering, formulations and technical transfers capacity...
£50k - £60k per annum
...targets, including OEE where applicable
* Provide direct interface as a subject matter expert with the QA department to interact with HPRA, FDA and applicable health authorities and internal audits.
What you need to apply:
* Minimum of 5 years experience in batch...
County Mayo
14 days ago
...experience acting as host of client and regulatory inspections quality is essential especially dealing with regulatory bodies such as HPRA & FDA.
• Meticulous attention to detail and high level of accuracy.
• Good working knowledge of pertinent regulations.
• Demonstrates...
€75k - €80k per annum
...effectively in a multi-discipline team structure.
- Familiarity with industry regulations and guidelines including ICH, cGMP, GAMP, PIC/s, HPRA & FDA.
Interested or know someone who might be? Reach out to __ using the following:
✉️
020 3530 5100
Apply now:...
...with quality related SOP’s.
Ensure successfully review, amendment and implementation of changes to SOP’s.
Need to front audits by HPRA/FDA or Customers on Control Systems.
Qualifications
Degree: Relevant Mechatronics / Engineering discipline
An excellent...
...solving and facilitation skills.
· Advanced PC skills such as Excel, Word, PowerPoint.
· Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.
· Experience in a FDA / HPRA Regulated production environment.
#LI-KV1...
...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...
...knowledge of aseptic processes' manipulation together with experience within a GLP/GMP environment and knowledge of current EU/FDA/ICH/HPRA guidelines.
* Lab experience within industry - Bioburden / Endotoxin / Growth Promotion / Environmental Monitoring.
* Experience within...
Team Horizon
County Mayo
4 days ago
...Provide guidance and support to suppliers to address any quality issues or non-conformances
Support and participate in external Audits (HPRA, Notified Body Audit, Customer Audits)
Provide support to Non-Conformance, CAPA, Change Controls and Documentation Control activities...
...with current good manufacturing practices (cGMP).
Act as lead for the Utilities Department in all regulatory inspections, e.g. FDA, HPRA, EPA, HSA, etc.
Review and report on current utility performance and implement continuous improvement projects and initiatives where...
...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...
...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.
Desirable:
Experience in direct interactions with...
...other teams.
Lead/participate in site GMP initiatives as required
Be up to date with current Quality guidelines e.g. ICH, GQMP, FDA, HPRA
Apply continuous improvement to the Quality processes using PPI tools and look continuously for process simplification opportunities...
Remote job
...aseptic cell culture techniques mandatory.
-Experience in in-vitro bioassays/potency assays highly desirable.
-Knowledge of current EU/ HPRA/ FDA/ICH/USP/EP guidelines
-Ability to problem solve and work on own initiative.
-Must Exhibit exceptional teamwork skills
About...
...activities
Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and HPRA).
Provide key support and technical expertise to the site to ensure people and technical skills are in place to implement new technologies...
