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

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