Qualified Person (QP) / Sachkundige Person (m/w/d)

A key strategic manufacturing location in Lower Saxony and operates as a centre of excellence for solid dose manufacturing, cephalosporin production, and clinical trial services. We are looking for an experienced Qualified Person to take on a critical and autonomous role within a high-performing quality organisation.

Responsibilities

• Exercising the function of Qualified Person (QP) / Sachkundige Person in accordance with all relevant legal and regulatory requirements (AMG, AMWHV, EU GMP Guidelines, CTR No 536/2014)
• Batch assessment and release of solid oral dosage forms (tablets, film-coated tablets, capsules, granules, sachets), cephalosporins, and IMPs for clinical trials, including third-party manufactured and imported products, in accordance with §§14/15 AMG, §16 AMWHV and applicable EU GMP provisions
• Ensuring compliance with legal requirements, alignment with IMPD submissions and product quality and safety standards
• Review, approval and processing of production and testing-relevant documentation including deviations, OOS results and validations
• Root cause analysis, pharmaceutical assessment and definition of CAPA measures for deviations
• Collaboration in cross-functional teams including supply chain management and analytical development
• Contributing to Quality Technical Agreements (QTAs) with partners, contract manufacturers, contract laboratories and other service providers
• Active participation in audits and inspections and assessment of new regulatory requirements and GMP developments
• Driving process improvement initiatives to increase efficiency and strengthen compliance
• Key point of contact for regulatory authorities, customers and internal stakeholders on batch release and quality compliance matters

Qualifications

• Degree in pharmacy, chemistry, biology, human medicine or veterinary medicine; formal qualification as Sachkundige Person pursuant to §15(1) AMG is essential
• Several years of professional experience in the pharmaceutical industry in quality assurance, manufacturing or testing of medicinal products
• Proven experience in batch release of solid oral dosage forms; experience with cephalosporin and/or IMP release highly desirable
• Strong knowledge of GMP regulations (EU, German, US/FDA) and international pharmaceutical law
• Experience in hosting and supporting regulatory authority inspections (BfArM, EMA, FDA)
• Strong analytical thinking with a systematic approach to problem identification and resolution
• Leadership capability to conduct solution-oriented technical dialogue across multiple departments and with external partners
• High degree of initiative, motivation and team-oriented working style
• Strong intercultural collaboration skills with a networked approach to building relationships with authorities, partners and customers
• Fluent German and English, both written and spoken