...validating, and revalidating all CGMP equipment, systems, and processes to meet global standards and regulatory requirements set by the FDA, HPRA, and other relevant authorities.
Key Responsibilities:
* Ensure compliance with validation requirements for new processes, equipment...
Westport, Co. Mayo
19 days ago
...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...
€ 60 - 67 per hour
...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 regulatory...
...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...
...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...
...Chemical Engineering discipline.
A minimum of 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....
...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...
...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...
...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...
...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.
~ Proven track record of leading and motivating a team.
~ Good...
...Chemistry/ Health Sciences fields.
- 1 - 3 years’ experience in pharmaceutical QC environment or equivalent
- Experience working in an HPRA/FDA regulated environment is essential
- Previous experience in equipment qualification/calibration activities
- Knowledge and...
...Participate in process, design & technical reviews with external clients
~Provide technical expertise during regulatory inspections e.g. FDA, HPRA inspections to defend systems, change controls, investigations and qualification packages
~Support transition from project to...
...regulatory files and ensure welfare accreditation is maintained.
· Participate in customer Animal Welfare audits and regulatory inspections (HPRA)
Requirements
You have a veterinary degree, recognized in Ireland, and be registered with the Veterinary Council of Ireland....
€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
4 days ago
...equipment/machinery and all aspects of performance around the production and packaging of the client products to customer requirements, FDA, HPRA, EPA and safety standards within budget parameters. This will be achieved by active communication and engagement with many stakeholders...
Team Horizon
Connacht
2 days ago
...solving andfacilitation 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 productionenvironment.
#J-18808-Ljbffr
PSC Biotech
Cork
4 days ago
...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...
Orion Group
Sligo, Co. Sligo
2 days ago
...(Control of Wholesale Distribution) Regulations 2007 (S.I. No. 539 of 2007), as amended, and any supplementary guidance issued by the HPRA.
PRIMARY DUTIES AND RESPONSIBILITIES:
Maintain the quality system and ensure that it demonstrates adherence to Good Distribution...
Cencora Global Procurement Limited
Cork
1 day ago
...-testing environment within the biological and/or pharmaceutical industry.
• Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory
MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12...
Kenny-Whelan & Associates
Ringaskiddy, Co. Cork
4 days ago
...extension, if you are looking for a new challenge – APPLY TODAY
Quality Assurance Specialist / QA / Quality Officer / Quality / QMS / HPRA / INAB / Pharmaceutical / Biologics / Life Science / Galway / Ireland
Job Title: Quality Specialist
Location: Galway...
Independent Search Solutions
Galway
3 days ago
...regulatory requirements.
Research, review and advise the business on any relevant supervisory authority’s regulatory requirements e.g HPRA requirements, Wholesale Distributor Authorisation framework
Correspond and successfully build relationships with relevant...
Phoenix Recruitment Limited
Connacht
2 days 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
4 days ago
...and tool
Professional certification, such as Six Sigma, CQE, or CQA
Experience on Pharmaceutical GMP environment accredited with HPRA and FDA
Proficiency in best practices for testing, version control, and defect management
In-depth knowledge of quality management...
Cpl Healthcare
Munster
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.
HPLC.
Capillary Electrophoresis.
UPLC/Mass Spec (desirable).
Excellent interpersonal skills...
Orion Group
Cork
2 days ago
...agency submissions and author responses to agency questions as required.
Participate in and support audits, both internal and external (HPRA/FDA etc.), including vendor and contract laboratory audits, as required, supporting the provision of response to applicable...
Bristol-Myers Squibb
Fingal
16 hours ago
...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...
Fastnet - The Talent Group
Sligo, Co. Sligo
4 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
4 days ago
...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...
Orion Group
Sligo, Co. Sligo
16 hours ago
...Manage packaging engineering changes to meet customer requirements and optimize OEE.
Generate packaging specifications compliant to FDA, HPRA, ISO and other relevant regulations.
Troubleshoot packaging processes and recommended improvements to streamline productivity output...
Viatris
Ireland
4 days ago