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Senior Operations Manager
Tipperary
Tipperary
Product Development Engineer
Galway
Galway
Clean Utilities Engineer
Carlow
Carlow
R&D Manager
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R&D Program Manager
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Senior R&D Engineer
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Carlow
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Carlow
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Galway
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Wexford
Manufacturing Engineer
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Galway
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Carlow
Quality Validation Engineer
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Manufacturing Engineer
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Galway
Senior R&D Engineer
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Waterford
E&I Turnover Engineer
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Carlow
Quality Engineer
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Galway
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Galway
Senior Electronic Engineer
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Principal R&D Engineer
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Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
EHS Systems Specialist
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Carlow
EHS Project Lead
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Cavan
Senior Project Manager - Process Develop
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Dublin South
Embedded Software Engineer
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Dublin
Engineering Projects Lead
Carlow
Carlow
Senior Electronic Engineer
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Dublin
R&D Engineer
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Dublin
Specialist Operations Engineer
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Tipperary
Product Development Engineer
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Facilities Engineer
Carlow
Carlow
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Senior Process Enginer
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Dublin South
Senior R&D Engineer
Clare
Clare
Quality Systems Manager
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Dublin
Senior R&D Engineer
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Dublin
Manufacturing Technician
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Clare
Process Engineer
Cork
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Project Engineer
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Product Development Engineer
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Galway
Senior QC Associate
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Carlow
Process Support Specialist
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Carlow
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Clare
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QC Laboratory Technician
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Manufacturing Shift Lead
Donegal
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Associate Director Quality Assurance
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Senior Associate Quality Control
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Embedded Software Engineer
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Quality Engineer
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Senior Regulatory Affairs Specialist
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Electronic Design Engineer
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Galway
Qualified Person
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Limerick
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Carlow
R&D Manager
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Galway
Senior Quality Engineer
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Director of Quality Engineering
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Limerick
Senior Quality Engineer
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Senior Validation Engineer
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Product Development Engineer
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Engineering Business Manager
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Chemical Engineer
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Associate Quality Specialist
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Quality Engineer
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Project Manager
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Distribution Centre Manager
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Galway
Validation Engineer
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Clinical Affairs Manager
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Project Manager - R&D
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R&D Director
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Process Engineer
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Quality Systems Specialist
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Galway
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Details
Qualified Person
Reference: | SCAXSG-348663 | Location: |
Limerick Limerick City |
Qualification: | Degree | Experience: | 5-7 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
Qualified Person
Qualified Person
Our 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 manufactured biotech drug substance (DS) batches are certified in accordance with all required regulations and in compliance with IND/CTAs/ manufacturing authorisation/ marketing authorisation
- Ensure that biotech drug product batches are tested in compliance with manufacturing & marketing authorisations (BLA/MAAs/ROW CTDs)
- Is responsible for the final decision associated with batch certification
- Ensures that the principles and guidelines of GMP as stated in 2003/94EC, 2001/83EC, 536/2014 (repealing 2001/20/EC), associated EU GMP annexes, (e.g., Annex 13, Annex 16) and current product specification file (PSF) are met
- Provide Quality leadership, direction, training and governance for the specific area of responsibility
- Carry out day to day activities in compliance with site safety policy and procedure
- Promote and encourage safe practices and promptly report any safety concerns
- Continue to maintain knowledge and experience in line with technical and scientific progress for product(s) of responsibility in alignment with Annex 16 requirements.
- Communication and education of personnel in GMP requirements and regulations.
- Responsible for approving appropriate quality-related documents. An approval signature confirms that the company, GMP and relevant regulatory requirements have been met
- Review and approve change controls, deviations, failure investigations, suspect analytical results, product quality complaints, stability studies and reports associated with the manufactured batches
- Review and approve GMP documents associated with qualification and validation including but not limited to change controls, IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes, stability data and periodic review reports (PRR) and annual product reviews (APR) product quality evaluations
- Responsible for issuance of QP declarations where required
- Understand the conditions and requirements when a renewed authorisation is necessary and ensure they are complied with
- Evaluation and contribution of regulatory information to regulatory documents including review/approval of dossier sections as part of the product submission processes
- BSc, MSc, or PhD in Biology, Chemistry, Pharmacy, or related discipline
- Must be approved by member state as a licensed QP in order to be named on the company licence as a QP
- Minimum of 7 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment
- Must have been on an Irish license previously as QP
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS