Job Description
The Qualified Person (QP) plays a pivotal role in ensuring the quality and regulatory compliance of biopharmaceutical products in a next-generation manufacturing facility. This position is responsible for implementing batch approval and regulatory authorization, collaborating with departments, and mentoring quality assurance teams. Key responsibilities include providing quality leadership, monitoring GMP compliance, reviewing and approving documents, and ensuring regulatory submission and batch approval. The ideal candidate will have a BSc, MSc, or PhD in Biology, Chemistry, or a related discipline, be a licensed QP, and have at least 10 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment. Strong understanding of cGMP, FDA, and biopharmaceutical regulatory requirements is also required.
- 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.
- 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.
- Monitoring of GMP compliance and verification of the effective implementation of key GMP programs and systems by ensuring a regular presence in the area of responsibility.
- Monitoring of the Site Self-Inspection program and audit of production, systems and service areas for compliance with Product Quality Systems, policies, guidelines and procedures.
- Responsible for approving appropriate quality-related documents.
- Review and approval of change controls, deviations, failure investigations, suspect analytical results, product quality complaints, stability studies and reports associated with the manufactured batches.
- Review and approval of GMP documents associated with qualification and validation.
- Review and approval of other key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documents.
- Familiar with the contents of or else involved in the review/approval of the applicable Quality Agreements.
- 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.
- Ensures 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.