Qualified Person

QP (Qualified Person)
RESPONSIBILITIES
- Content and format verification of release documentation (shipping documents, documentation of raw materials, completed production records, in-process control results, specification(s), evaluation of QC results, release checklist, etc.- Evaluation of release documentation for batch(es) intended for clinical trials.- Preparation of statements and release certificates for clinical batches.-Preparation of rejection statements for clinical batches.- Involvement in the disposal of rejected clinical batches.- Coordination of complaint and recall processes, liaison with authorities.- Participation in preparation for inspections initiated by request or regulatory authorities, presence during inspections, and professional representation regarding relevant topics.
Other responsibilities (e.g. those related to setting up the laboratory):
- Conducting process-based internal audits in the laboratory and making improvement recommendations.- Supporting the integration of GxP documents into the documentation system of the laboratory.- Providing assistance in the selection of laboratory software. Involvement in the compilation and verification of the software validation package.

REQUIREMENTS:
- Proven experience as a Qualified Person, a minimum of 5 years of relevant experience working in a pharmaceutical or biotechnology company, with a proven track record in a QP or similar role.- Certification as a Qualified Person (QP) in accordance with applicable regulatory requirements is mandatory.- Comprehensive knowledge of pharmaceutical regulations, including Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant quality and compliance standards.- Extensive experience in batch certification and release processes, including the review and approval of batch documentation.- Proficiency in quality assurance processes and documentation, with a strong understanding of quality systems, deviations, change control, and investigations.- Experience in an aseptic manufacturing environment.- Experience with active biological ingredients.
Requirements to comply with:
- Adherence to EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines.- Compliance with the Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (Text with EEA relevance) (2013/C 343/01).- Conformance with MSZ EN ISO 9001:2015 (ISO 9001:2015) standards.- Implementation of Good Pharmacovigilance practices.- Abiding by Regulation 39/2004 (IV. 26.) of the Ministry of Health regarding the qualification requirements for persons authorized for the quality assurance of medicinal products.- Compliance with Regulation 44/2004 (IV. 28.) of the Ministry of Health on the prescription and dispensing of medicinal products for human use.