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