YOUR TASKS AND RESPONSIBILITIES

• Responsibility for batch confirmation of bulk drug product batches and certification of semi-finished drug product batches according to DIRECTIVE 2001/83/EU of the EU in accordance with the requirements of the marketing authorization (MA), GMP and other relevant legal requirements
• Review of the manufacture and QC testing including correspondent deviation reports and OOS-/ OOT reports at batch disposition
• Approval of change applications including determination of the required measures for implementation and consideration of the release of the batches
• Management and assessment of complaints and ensuring that these are processed in accordance with global guidelines and legal requirements
• Approval of Product Quality Reviews

WHO YOU ARE

• University degree in pharmacy
• Qualification as Qualified Person according to Article 49 of Directive 2001/83 (§15 AMG)
• Long-term experience in pharmaceutical production and quality control of solid dosage forms
• Very good knowledge of the GMP-compliant production and testing of solid dosage forms with regard to pharmaceutical regulations (EU-GMP Volume IV, German Medicinal Products Act, CFR 21 Part 210/211)
• Very good team and organizational skills
• Good judgment, stress resistance and assertiveness
• Business fluent in English and German, both written and spoken