QA Manager/QP

Your new companyWe are looking for a Quality Assurance Manager & Qualified Person for our pharmaceutical partner.
Your new role
As a Quality Assurance Manager

• ensure the highest standards of pharmaceutical quality assurance and batch release compliance
• development of pharmaceutical quality assurance in contracts, supplier and subcontractor quality assurance assessmentssupport for process improvement, ensuring compliance with applicable Hungarian laws, GMP, and GMP expectations documented by the local CRO in the country conducting clinical trials
• responsibilities include compliance with and enforcement of procedures, ensuring transparency throughout the product lifecycle and product safety
• execution of other pharmaceutical quality assurance activities aimed at ensuring GMP manufacturing conditions for clinical trials, including occasional inspections

As a Qualified Person

• content and format verification of release documentation
• 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

What you need to succeed

• pharmacist degree
• fluent English (written and spoken)
• proven experience in quality assurance management or/and Qualified Person, with a minimum of 10 years in a similar role within the pharmaceutical, biotechnology, or healthcare industry
• comprehensive knowledge of pharmaceutical regulations, including Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant quality and compliance standards.
• experience in hosting and participating in regulatory inspections and audits, with a thorough understanding of regulatory requirements and expectations
• experience in an aseptic manufacturing environment
• understanding of international and local regulations governing pharmaceutical and biotechnology products, including FDA and EMA requirement

What can you expect from our partner

• Competitive salary package
• Experience in a wide range of indications, in particular in the repositioning of medical devices, vaccines, and investigator-initiated studies.
• Innovative company culture
• Contribute to the company's mission of making a positive impact on healthcare through groundbreaking research and development

What you need to do nowIf you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.