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 an Irish licence.
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).Be responsible for the final decision associated with batch certification.Ensure 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.Communicate and educate personnel in GMP requirements and regulations.Be 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.Be 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.Evaluate and contribute 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 ******
#J-18808-Ljbffr