QA Director

Main Responsibilities :

• Ensure that each GMP batch of a medicinal product is manufactured and analyzed in accordance with the GMP Guidelines and European Directive 2001 / 83 / EC, as amended, the quality and technical agreements, and the marketing authorization.
• Certify and release (or reject) of medicinal product batches for the EU / EEA, US, and export markets in accordance with Section 19 of the German Medicinal Products Act (AMG), Section 16 of the German Medicines and Healthcare Products Act (AMWHV), Annex 16 and Annex 13 of the EU GMP Guidelines or the Commission's detailed guidance of December 8, 2017, and enter them into a batch register.
• Verify that each batch of a medicinal product is distributed under conditions that comply with the GDP Guidelines according to Chapter 2.2 of the European GDP Guidelines.
• Assess deviations and changes with regard to compliance with GMP and regulations.
• Participate in the assessment of pharmaceutical-technical complaints and product returns. Decision on quarantine status and possible product recall (EU). Participation in the coordination and management of product recalls (EU)
• Review / evaluate data provided by internal departments and / or external partners, as needed, regarding quality oversight for the relevant products
• Support in ensuring that the CMOs' activities and the services provided are in compliance with FDA, EMA, and other global regulations and guidelines, ICH guidelines, corporate policies, SOPs, and site best practices
• Decision-making on initiating recalls in coordination with the relevant authorities
• Participation in external audits and self-inspections, as well as qualification of contract manufacturers and distributors, evaluation of audit reports
• Assumption of responsibility for quality communication, review and preparation of technical and quality agreements with assigned partners
• Support in regulatory and other inspections and audits
• Improvement and updating of relevant quality system documents and work instructions
• Review and approval of annual product quality reports
• Assessment of customs and pharmaceutical regulatory requirements for the import and export of starting materials Finished medicinal products and investigational medicinal products
• Supervision of the import of medicinal products into the warehouse in Germany
• Participation in inspections by the competent authorities and follow-up in consultation with management
• Managing the storage of sample documents
• Maintaining the site's GMP / GDP compliance

Qualifications and Experience :