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Process Support Specialist
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Carlow
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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