▷ Apply in 3 Minutes Quality Specialist
2 weeks ago
Quality Specialist required for a leading Biopharma facility in South Tipperary, to support the Quality Systems activities in both the Drug Substance and Drug Product facilities. The Quality Specialist participates as a member of the Quality Systems Team. Initially an 11 month contract. Please contact Claire ROLE To provide leadership, through knowledge and skill regarding the validation standards required for a Drug Substance and Drug Product (SDI & OSD) pharmaceutical facility. o Includes participating in and supporting the site PVC (Process Validation Committee), WVC (Water Validation Committee), CVG (Cleaning Validation Group),) and Equipment Qualification Validation Committee (EQVC). o Approval of all validation documentation and ensuring compliance to policies, procedures and guidelines. Ensures that validation status is maintained following changes/modifications. o Supports the implementation of site or capital projects by defining validation requirements and providing technical assistance and support as a member of the project teams. o Develops Validation Summary Reports and assist in developing overall Quality plans for major projects. o Works with other areas and industry to predict future trends in validation and to determine best practice. o SAP Quality Process Steward Quality SME for Change Control. o Principle Quality contact for all site change requests (with impact on processing) Provide Quality and change analyst review for all change requests through all the stages of the change control process ensuring compliance with site policies, procedures and guidelines. Principle Quality contact for all Quality assessment of material control strategies associated with change requests for processing and analytical changes. Laboratory QA oversight o Support and approve the systems supporting laboratory functions, instrumentation and GLIMS. Provide Quality oversight and approval for laboratory incidents / investigations and documentation. o Stability oversight: Review and approval of stability reports (Intermediate and API stability data and reports are reviewed for accuracy and to support OOS and investigations as appropriate). o Microbiology Point of Contact. Knowledge of microbial requirements in the pharmaceutical industry, to liaise with site Microbiologist for all microbial issues e.g. water, utilities, environment, excipient or product and as necessary. Quality Agreement System Management o Manage the site inventory of Quality Agreements to ensure Quality Agreements are raised for all required relationships. Interact and communicate with SD&PM, relevant stakeholders and external parties to ensure appropriate Quality Agreements are current, approved, on file and retrievable. Annual Review System Management o Manage the system ensuring that Annual Reviews (AR/APR/PQR) for products and systems incl automation, are completed to meet the Annual Review schedule. Creation, review and approval of Site Quality documentation including. o Site Master File, Validation Master Plan, policies or procedures. Quality Oversight of site application User Access Reviews o Approval of all designated user access reviews, ensuring compliance with site policies and procedures. o Participate in the investigation and review of any internal / external customer complaints in accordance with agreed lead-times. o Participate in the investigation and review of any supplier complaints in accordance with agreed lead-times. Filing & Licence maintenance and Regulatory Requests follow ups o Review and ongoing maintenance of site licences. o Provide site documentation to support product filings in accordance with CMC requests. QA Regulatory Data: o Review and verify documentation that may be used for submission to Pharm - CMC or other requester(s) for regulatory submissions/filings. Assure the accuracy and integrity of all data and information through a timely review program. Returned Goods o Manage the segregation and disposition of all returned goods. Audit program o Support the internal GMP walk-down and scheduled audits program. o Support hosting of site Regulatory Inspections. Qualifications & Education Minimum of Degree or post-graduate qualification in Science, Pharmacy or Engineering field At least 1-2 years experience in the pharmaceutical industry Benefits: Quality Specialist Pharmaceutical Science
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Quality Specialist
2 weeks ago
Tipperary, Ireland PE Global Full timePE Global are currently recruiting for a Quality Specialist Quality Systems for our client site in Tipperary: 11 month initial contract Role Description The Quality Specialist Quality Systems supports the Quality Systems activities in the both the Drug Substance and Drug Product facilities. The Quality Specialist participates as a member of the Quality...
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Quality Systems Specialist
2 weeks ago
Tipperary, Ireland Headcount Solutions Full timeQuality Systems Specialist An opportunity has arisen for a Quality Specialist to support the Quality Systems activities in both the Drug Substance and Drug Product facilities within a leading Biopharma Multinational based in the North Munster region. Key Responsibilities: Provide leadership, regarding the validation standards required for Process, Cleaning,...
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Quality Systems Specialist
2 weeks ago
Tipperary, Ireland Headcount Solutions Limited Full timeQuality Systems SpecialistAn opportunity has arisen for a Quality Specialist to support the Quality Systems activities in both the Drug Substance and Drug Product facilities within a leading Biopharma Multinational based in the North Munster region.Key Responsibilities: * Provide leadership, regarding the validation standards required for Process, Cleaning,...
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3 Days Left: Quality Specialist
2 weeks ago
Tipperary, Ireland Life Science Recruitment Ltd Full timeQuality Specialist - Change Control Lead RK22648 Contract 11 months Tipperary Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. The successful applicant will...
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Quality Auditor
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Tipperary, Ireland Recruitment by Aphex Group Full timeQuality Auditor Purpose The Quality Specialist Quality Systems supports the Quality Systems activities in the both the Drug Substance and Drug Product facilities. The Quality Specialist participates as a member of the Quality Systems Team. Responsibilities Sub System Ownership: Complete sub system ownership responsibilities as per the site System Ownership...
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▷ Apply in 3 Minutes! Change Control Lead
1 week ago
Tipperary, Ireland Recruitment by Aphex Group Full timePurpose Exciting opportunity exists for a Change Control Lead, to join a highly skilled Project team supporting a large-scale capital. Responsibilities The successful applicant will be responsible for initiation, ownership and management of changes through the change control system. Collaboration with change initiators, subject matter experts, reviewers,...
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▷ Apply in 3 Minutes! Call Centre Agent Clonmel
2 weeks ago
Tipperary, Ireland Hays Specialist Recruitment Ireland Ltd Full timeYour new company Your new company is a global organisation within the IT industry with multiple sites across Ireland. They are a recognised employer of choice and due to new business, we are hiring an enthusiastic team of customer service agents to work part-time in Ireland. You will receive fully paid in office training in their office location in Clonmel....
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▷ (Apply in 3 Minutes) Product Builder - A2
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Tipperary, Ireland Boston Scientific Limited Full timeAdditional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest...
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Tipperary, Ireland EPS Group Full timeAbout the Role: This is a multi-disciplined organisation and job role, so all experienced applicants from associated disciplines are welcome. EPS require a Water Treatment Plant Operator to work on a term contract as a treatment plant operator in the Tipperary/Limerick region. The role requires a good understanding of both the Water and Wastewater Treatment...
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Tipperary, Ireland LGC Limited Full timeJob Description We are seeking a dynamic and experienced R&D Project Manager to lead and oversee multiple new product development projects within the pharmaceutical, biotechnology and AgBio sectors. The ideal candidate, will be responsible for planning, executing, and finalizing projects, to a high Quality driven standard and according to strict deadlines...
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Senior HR Manager New
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Tipperary, Ireland CPL Full timeSenior HR Manager Are you a experienced HR professional who is now looking for a new challenge? Or are you looking to take a step up in your career & take on a lead & senior level HR Manager role? Our client, a major player in the engineering, construction & facilities sector are now expanding their leadership team & have engaged with us in Cpl to help...
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Mechanical Project Engineer
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Tipperary, Ireland Sigmar Recruitment Full timeAbout Your New Employer Leading renewable energy company with multiple large-scale projects across Ireland At the forefront of Ireland's transition to sustainable energy, with significant investment in expanding their renewable portfolio Strong focus on employee development, with clear progression paths and investment in upskilling their team About Your New...
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Urgent: Quality Specialist
2 weeks ago
Tipperary, Ireland PE Global Full timePE Global are currently recruiting for a Change Control Lead for our client site in Tipperary: 11 month initial contract Predominately based onsite but there is an element of working from home Overview Exciting opportunity exists for a Change Control Lead, to join a highly skilled Project team, based on site in Tipperary, supporting a large-scale capital...
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Technical Development Specialist
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Health and Safety Specialist
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▷ (Urgent) Quality Engineer
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Tipperary, Ireland RPG Recruitment Full timeQuality Engineer rolein a leading mechanical and electrical engineering company based in South Tipperary. Reporting to the Production and Purchasing Manager and joining an expanding team at a time of large growth. As a Quality Engineer, you will collaborate closely with project managers, subcontractors, and stakeholders in ensuring excellence inquality...
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▷ 3 Days Left! Health
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Tipperary, Ireland Arrabawn Full timeOVERVIEW Arrabawn is a leading dairy processing and Agri-supply business with a century plus history of operations across three of Ireland's four provinces. Having undertaken a significant programme of investment, Arrabawn is a company faced very much to the future, operating with what are among Ireland's most modernised dairy processing facilities....
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▷ (Apply Now) Psychiatric Nurse
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Tipperary, Ireland Nua Healthcare Full timeExpanding mental health service - Now recruiting for all nurse grades. Starting Salary above HSE scale - Along with Excellent Terms and Conditions. Nua Healthcare Services (Nua) is one of Irelands leading Private Healthcare Providers, specialising in Residential and Supported Living Services, to both Children and Adults with a range of complex support needs....
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Apply Now: Locum Consultant Physician
2 weeks ago
Tipperary, Ireland TTM Healthcare Solutions Full timeTTM Healthcare are currently recruiting aLocum GIM Consultant for a role in Tipperary. If this opportunity is of interest to you, whatsapp Roisin McSweeney on / click APPLY NOW or / email today to arrange an interview. TTM has been awarded Tier 1 supplier status by the HSE for the provision of recruiting locum doctors of all grades and specialties...
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Quality Change Control Lead
2 weeks ago
Tipperary, Ireland Headcount Solutions Limited Full timeQuality Change Control LeadAn exciting opportunity exists for a Change Control Lead, to join a highly skilled Project team, based on site at a Tipperary based Pharmaceutical multinational. The successful candidate will be involved in supporting a large-scale capital project. The role will be responsible for the ownership and management of changes through the...
