Average salary: €88,215 /yearly
More statsSearch Results: 23 vacancies
€90k per annum
...dedicated to delivering top-quality medicinal products manufactured in-house. We are currently seeking a Head of Quality & Qualified Person (QP) to oversee our quality management processes and ensure compliance with regulatory standards.
Responsibilities:
Lead the...
...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...
...centre that underpin a strong commitment to health and wellbeing.
About the job
Our Team:
The Quality Assurance team is made up of QP’s, Managers, Technical Leads, Team Leads and Quality Specialists, all of whom are dedicated to transforming the practice of medicine by...
...introductory paragraph here if available
Every day, we rise to the challenge to make a difference and here’s how the Qualified Person (QP) role will make an impact:
Perform QA/QP batch release as required to support operational business requirements (the job holder is...
...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...
...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...
...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...
...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...
£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...
...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...
...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...
...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...
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...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...
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...maintenance of Global External Quality Management Systems (QMS) and the BLIL Quality Management System.
KEY RESPONSIBILITIES:
The QP must be eligible to act as a European Qualified Person (QP), certifying products in compliance with 2001/83/EC, 2003/94/EC and Annex 16....
...responsibility of the European Union Qualified Person for Pharmacovigilance (QPPV).
Ensure support is provided to enable the QPPV to fulfil the QP legal responsibilities.
Other Job expectations
A GPS Medical Global Medical Review Advisor/Senior Advisor is expected to:
Meet...
...The QP is the person responsible for ensuring batch production compliance with EU regulations and handing off to CMO or partner QP for final release of batches of Gene Therapy and RNA products. The QP will work with Sarepta QA operations and CMOs to assess the manufacturing...
...investigations, deviations and CAPAs).
~Generation of Product Specification Files or Technical Review Files.
~Act as a Qualified Person (QP) named on Jazz Pharmaceuticals Manufacturing and Import Authorization (MIA) for Investigational Medicinal Products to ensure clinical...