Average salary: €88,215 /yearly
More stats ...benefit from exemplary work across our entire range of professional services.
Requirements include:
We are now seeking a Qualified Person (QP) to join our growing operations in Ireland. The role of a QP in CAI is to:
- The Qualified Person is responsible for certifying...
...and expertise for New Product Introductions
Review and approve Non-Conformances (NC), CAPA, change controls and complaints.
Perform QP disposition, ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State...
Bausch & Lomb GmbH
Dublin
2 days ago
...drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
· Perform and review complaints and deviation investigations, change controls and CAPA’s.
· Creates and maintains...
...client, a global biotech,are seeking a highly motivated and detail-oriented Qualified Person to join the quality assurance team as the Lead QP onsite. The successful candidate will have previously been a named QP on a Irish licence previously. Responsibilities
~Ensure...
€90k per annum
...internal and external compliance.
Embed QMS management principles in the organisation & drive continuous improvement.
Liaise with the QP on performance of the QMS and emerging quality trends and risks.
Lead continuous improvement initiatives to ‘challenge’ the quality...
Dublin
24 days ago
...with same.
~ Support the development and implementation of improved quality reporting measures.
~ Liaise with the Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing process.
· Quality Oversight:
Work collaboratively to drive a safe...
...are made to meet project deliverables and longer-term strategic goals for the site
Requirements
~Bachelor of Science, Engineering, QP or equivalent Quality Management Qualifications
~Preferred
~ 6 years GMP Manufacturing experience and at least 1 year experience in leading...
£25k per annum
...provide proactive plan
OFFICE:
To participate in the on-call phone on alternative weeke nds.
To participate on updating the QP platform with any changes to rostering when it's your working weekend.
Completion of weekend handover required.
To work with...
...other stakeholders to address product quality issues, conduct impact assessments, and communicate effectively with Qualified Persons (QP), clients, and regulatory bodies.
Knowledge, Skills and Experience Required for the Role:
~ Advanced degree (Bachelor, Master, or...
...documents from end-to-end, covering warehouse and supply chain management operations, manufacturing operations, batch certification by QP, batch release and shipment for biologics drug substance manufactured in their Biologics facility in Ireland.You will be reporting to the...
...drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
Perform and review complaints and deviation investigations, change controls and CAPA’s.
Creates and maintains...
Life Science Recruitment
Munster
3 days ago
...leadership and direction on product quality investigations, critically assess and support impact assessments where needed and liaise with QP, Client and/or CMC regulatory affairs with regard to mitigations such as change controls, variations etc
~Develop and implement the...
...maintained.
Education and Experience:
Third level qualification (degree in science or related discipline preferred) appropriate for QP eligibility
A minimum of 10 years of related experience in the pharmaceutical/biotechnology industry with at least 5 years relevant...
...drug product, and packaged finished goods releases, ensuring alignment with SOPs, GMP, and regulatory standards, including facilitating QP certification.
Execute and review complaint and deviation investigations, change controls, and CAPAs.
Develop and maintain designated...
Sigmar Recruitment
Munster
4 days ago
...Job Description
A fantastic opportunity has arisen for a Senior Specialist, QP at our site in Brinny, Co. Cork. The QP will form active partnerships across all areas of the site, providing independent quality support, guidance and expertise to a diverse variety of functions...
Merck Sharp & Dohme Corp.
Cork
1 day ago
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Wright Concrete Products
Ulster
1 day ago
...batches for sale or supply in compliance with regulations.
Responsibilities:
Complies with the responsibilities of Qualified Person (QP) stated in directives issued by EC. Certifies batches for sale or supply in compliance with regulations.
Approves Annual Product...
Tandem Project Management Ltd.
Cork
1 day ago
...0B=@+?~Yϰ *'(^q53j*-&RbH wMe/%AZ3M?Zc7F곊0:K5si/Xk/\E ^; yBIMP!P xSԙԑ__01͖.`| qta'#x%xU]7 n\D2bSl?㽋gc#lZaV$+$vaa!****@*****.*** 5f:51d:q'cEI\Qp^^}Ф*kKuJxE'6O'LH\]ˏ[),h-Aү^XL'{u# SU.%MA&_^/Б#Yi=ޮ$0띱 [m'*hqVӸy/"Ex(en;Z-OOuD8cDl0 w7qA l%~{so$JK %Rk3Ȏe0X6N#=f[$zOpm8ւT靧}1L#91{8RSpl$bN...
Independent Vetcare Ireland Limited
Ireland
1 day ago
...quality assurance team and ensure the highest standards of product quality and compliance.
Position Summary: The Qualified Person (QP) plays a pivotal role in ensuring the quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing...
Eli Lilly and Company
Munster
2 days ago
...with site best practices in both electronic and paper based systems Perform detailed batch record review of finished products prior to QP/QA release.
Assist with the maintenance of the incident report system, supplier non-conformance system and the CAPA system.
Perform...
Viatris Company
Ireland
17 hours ago
...Associate Director, QP Operations page is loaded Associate Director, QP Operations
Apply locations Cruiserath - IE Utrecht - NL time type Full time posted on Posted 3 Days Ago job requisition id R1581239 Working with Us
Challenging. Meaningful. Life-changing. Those...
Bristol-Myers Squibb
Fingal
3 days ago
...role works to build effective partnerships with Quality counterparts at both the CMO and with internal departments (e.g., QA Operations, QP, Compliance, Quality Control, Regulatory) to assess the health of the CMO, improve and reduce risk at CMO operations and ensure that all...
BIOMARIN
Cork
2 days ago
...Executive II (6 Month Fixed Term Contract) role will make an impact:
Perform detailed batch record review of finished products prior to QP/QA release.
Assist with the maintenance of the incident report system, supplier non-conformance system and the CAPA system....
Viatris Inc.
Ireland
2 days ago
...Executive II (6 Month Fixed Term Contract) role will make an impact:
Perform detailed batch record review of finished products prior to QP/QA release.
Assist with the maintenance of the incident report system, supplier non-conformance system and the CAPA system....
Viatris Company
Ireland
2 days ago
...Quality Operations Manager role will make an impact:
Ensure that the manufacture and release of site products are in alignment with QP EU directives, relevant health authority submissions, cGMPs as well as company policies and procedures.
Provide strategic and technical...
Viatris
Dublin
4 days ago