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.
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Részletes információk az állásajánlatról
Vállalat: HAYS Hely: Budapest
Budapest, BudapestMunkaviszony: Permanent Hozzáadva: 16. 1. 2025
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