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.ResponsibilitiesExercising 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 provisionsEnsuring compliance with legal requirements, alignment with IMPD submissions and product quality and safety standardsReview, approval and processing of production and testing-relevant documentation including deviations, OOS results and validationsRoot cause analysis, pharmaceutical assessment and definition of CAPA measures for deviationsCollaboration in cross-functional teams including supply chain management and analytical developmentContributing to Quality Technical Agreements (QTAs) with partners, contract manufacturers, contract laboratories and other service providersActive participation in audits and inspections and assessment of new regulatory requirements and GMP developmentsDriving process improvement initiatives to increase efficiency and strengthen complianceKey point of contact for regulatory authorities, customers and internal stakeholders on batch release and quality compliance mattersQualificationsDegree in pharmacy, chemistry, biology, human medicine or veterinary medicine; formal qualification as Sachkundige Person pursuant to §15(1) AMG is essentialSeveral years of professional experience in the pharmaceutical industry in quality assurance, manufacturing or testing of medicinal productsProven experience in batch release of solid oral dosage forms; experience with cephalosporin and/or IMP release highly desirableStrong knowledge of GMP regulations (EU, German, US/FDA) and international pharmaceutical lawExperience in hosting and supporting regulatory authority inspections (BfArM, EMA, FDA)Strong analytical thinking with a systematic approach to problem identification and resolutionLeadership capability to conduct solution-oriented technical dialogue across multiple departments and with external partnersHigh degree of initiative, motivation and team-oriented working styleStrong intercultural collaboration skills with a networked approach to building relationships with authorities, partners and customersFluent German and English, both written and spoken #J-18808-Ljbffr
Standorte
Qualified Person (QP) / Sachkundige Person (m/w/d) in Göttingen, Wietze Arbeitgeber: Vector Talent
Unser Unternehmen in Göttingen bietet eine dynamische und unterstützende Arbeitsumgebung, die auf Wachstum und Innovation ausgerichtet ist. Als Arbeitgeber investieren wir aktiv in die Entwicklung unserer Mitarbeiter und fördern eine Kultur der Zusammenarbeit und des kontinuierlichen Lernens. Die Position als Site Finance Analyst ermöglicht es Ihnen, direkt Einfluss auf die Finanzstrategien zu nehmen und dabei von flexiblen Arbeitsmodellen zu profitieren, die eine ausgewogene Work-Life-Balance unterstützen.
