-
Compliance Specialist
6 days ago
Headcount Limerick, IrelandCompliance Specialist – Technical Operations · The Compliance Specialist, Technical Operations is a member of the Technical Operations Team (Automation, Engineering & Facilities) and is responsible for operations support and compliance related activities for the manufacture of s ...
-
Environmental Compliance Specialist
5 days ago
Thermo Fisher Scientific Cork Co., Ireland Full timeJob Description · Job Title: Environmental Compliance Specialist (12month Contract) · Location: Ireland - Cork Co., Currabinny, Carrigaline · Shift: Mon - Thurs 8:30am - 4:45pm and Fri 8:30am - 3:30pm · When you're part of the team at Thermo Fisher Scientific, you'll do meaningfu ...
-
Senior accounts assistant
8 hours ago
Hays Specialist Recruitment Limerick, IrelandAre you looking for a new opportunity and live close to the West side of Limerick city? Currently, we are sourcing for a client in the Limerick area to add another team member to their growing finance team. The ideal applicant will have an accounts assistant/payroll background wi ...
-
Insurance Broker
1 week ago
Engage People Limerick, Ireland Full timeDo you want to work with a leading broker in the insurance market? Including a competitive base salary, a bonus structure, and a clear progression path? · If you have made it this far keep on reading... · About the Company · This broker has a proud history within the insurance ma ...
-
Architectural Technologist
1 week ago
Elk Recruitment Limerick, Ireland Full timeRole: Architectural Technologist · Location: Limerick · Salary: Negotiable DOE · Our client is an accomplished and expanding, third generation architectural practice based in Limerick City. Work consists of a wide range of projects in the healthcare, commercial, education and tec ...
-
Facilities Manager
2 weeks ago
Elite Talent Hub Limerick, IrelandElite Talent Hub LTD is a specialist in permanent staffing solutions for clients nationwide. · Our client, is currently seeking a Facilities Manager for a Hospital based in Limerick. Role is fulltime, pensionable and paying up to €75,000 DOE, plus benefits and pension. · Purpos ...
-
Regulatory Operations Specialist I
1 week ago
Uber Limerick, IrelandAbout the Role · At Uber, we strive to deliver safe transportation to all users of our application. By ensuring we are adhering to all of our Regulatory and Compliance requirements associated with our Rides business, allows us to safely operate in 58 jurisdictions across the UK ...
-
eCommerce Analytics Manager
1 week ago
Henry Schein Limerick, Ireland Full timeJob Description · An Analytics Manager in EMEA plays a crucial role in steering data-driven decision making within Henry Schein EMEA. This position involves overseeing the collection, analysis, and interpretation of data to improve business processes, enhance decision-making, and ...
-
QA Specialist
1 day ago
Cpl Limerick, Ireland FreelanceQA Specialist · This role participates in maintaining site compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities, Maintenance, Engineering, Materials Handling, and QA Validation in accordance with m ...
-
eCommerce Analytics Manager
2 days ago
Brasseler USA Inc. Limerick, IrelandeCommerce Analytics Manager - EMEA page is loaded · eCommerce Analytics Manager - EMEA · Apply remote type Hybrid locations Limerick time type Full time posted on Posted 4 Days Ago job requisition id R126991 Job Description · An Analytics Manager in EMEA plays a crucial role ...
-
Senior Director, Engineering
6 days ago
Johnson & Johnson Limerick, IrelandJob Description - Senior Director, Engineering & Construction Safety Center of Excellence W) · Senior Director, Engineering & Construction Safety Center of Excellence W · Description · Johnson & Johnson is recruiting for a Senior Director, Engineering & Construction Safety Ce ...
-
Facilities Manager, Ireland West
5 days ago
Cpl Limerick, Ireland Full timeFacility Managers in the West of Ireland, we have an exciting opportunity for you to Manage hard services FM (mechanical / Electrical)and technical FM. You will take ownership of the upkeep and maintenance of this new state-of-the-art Testing and Analysis Facility. The facility i ...
-
Technical Regulatory Specialist
5 days ago
Northern Trust Limerick, Ireland Full timeAbout Northern Trust: · Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889. · Northern Trust is proud to provide innovative financial services and guidance to the world's most succe ...
-
Customer Operations Specialist
2 weeks ago
Stryker Limerick, Ireland Paid WorkWhy customer service at Stryker? · Are you interested in making a difference in healthcare by assisting sales reps and building relationships with customers? As a member of our customer services team, that is exactly what you will do Here, you will be a part of a dynamic and supp ...
-
Catering Assistant
2 days ago
Corporate Catering Contract Catering Clare, IrelandCCSL is known as one of Ireland's most experienced workplace catering experts, we are passionate about great food, sustainability and provenance. Putting our employees and customers first is at the heart of everything that we do. We wish to recruit a Catering Assistant for the Mo ...
-
Global Payroll Specialist
1 week ago
AXA Group Shannon, Ireland Full timePOSITION SUMMARY: · We are looking for a dedicated Payroll Specialist to join our AXA Partners globalpayroll team based in Shannon, Ireland, and support all payroll activities for multiple countries. · What you will be doing: As a Payroll Specialist at AXA Partners, you will hav ...
-
Quality Specialist
5 days ago
Recruitment by Aphex Group Tipperary, IrelandThis is an 11-month initial contract. Purpose The Specialist is a member of a team within Quality and is involved in supporting the GMP Quality Assurance activities onsite. Responsibilities Review and approve production and analytical documentation accompanying the release of dru ...
-
QA Specialist
6 days ago
Tandem Project Management Limited Tipperary, IrelandSummary: A QA Specialist is required for a pharmaceutical company in South Tipperary. The successful candidate will be involved in supporting the GMP Quality Assurance activities on site. Responsibilities: Review and approve production and analytical documentation accompanying th ...
-
Senior Occupational Therapist
1 week ago
Nua Health Care Newmarket, IrelandJob Summary · Nua Healthcare Services (Nua) is one of Ireland's leading Private Healthcare Providers, specialising in Residential and Supported Living Services, to both Children and Adults with a range of complex support needs. · We are seeking applications from energetic and en ...
-
Quality Specialist
1 week ago
PSC Biotech Ltd Tipperary, IrelandJob Description · About PSC Biotech · Who we are? · PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countri ...
Compliance Specialist - Limerick, Ireland - Hanley Calibration
Description
Summary:
The Compliance Specialist, Technical Operations is a member of the Technical Operations Team (Automation, Engineering & Facilities) and is responsible for operations support and compliance related activities for the manufacture of products on a Biopharmaceutical Facility in Co. Limerick..
Essential Duties and Responsibilities include, but are not limited to, the following:
Completes investigations of technical deviations for department issues of non compliance. Ensures CAPAs are identified as appropriate and are implemented as planned; in addition, ensures CAPAs have the intended effectiveness.
Acts as a liaison between Technical Operations and onsite quality and regulatory groups, as well as other departments across the company, with respect to all quality instances and compliance support.
Provides support, information, and assistance to individuals, groups and management with the initiation, authorship, review, submission, and follow-up/completion of documents such as Change Controls, risk assessments, impact statements and corrective/prevention action plans.
Provide periodic review of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, Life Cycle Documents and Engineering Documetation, etc. to assess for compliance with established quality standards, policies and procedures.
Review and approval of preventative maintenance records/work orders (corrective and scheduled) on the CMMS system to assess for compliance with established quality standards, policies and procedures.
Maintains knowledge of current good manufacturing practices (cGMPs) and execution of any other GMP compliance related activities as required.
Continious Improvement Implementation.
Knowledge, skills and abilities:
Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments.
Strong interpersonal, written, presentation, communication and investiagtion skills with the ability to engage with a diverse range of individuals across all levels of the organization.
Education and Experience:
Specialist; minimum of BA/BS in Engineering/Science discipline with 2+ years experience working in a cGMP environment.