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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Qualified Person


Reference:SCAXSG-348663 Location: Limerick
Limerick City
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: 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
Requirements
  • 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
For more information contact Sinéad Cullen on +3538795009821 or [email protected]