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

Vector Talent; Göttingen; On-site; EUR 120,000 - 150,000; Full time

Job summary

Vector Talent in Germany is seeking an experienced Qualified Person to lead batch release and regulatory compliance within a high-performing quality organisation. You will ensure GMP-aligned release of solid dosage forms, engage with authorities, and drive continuous improvement across QA, manufacturing and QA documentation.

The role demands a pharmacology or chemistry background, formal Sachkundige Person qualification, and excellent German and English communication to coordinate with partners,

Qualifications

• Formal qualification as Sachkundige Person pursuant to §15 AMG is essential.
• Several years of professional experience in quality assurance, manufacturing or testing of medicinal products.
• Proven experience in batch release of solid oral dosage forms; cephalosporin/IMPs release desirable.

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 for clinical trials, including third-party manufactured and imported products, in accordance with AMG/AMWHV and EU GMP provisions
• Ensuring compliance with legal requirements, alignment with IMPD submissions and product quality standards
• Review, approval and processing of production and testing documentation including deviations, OOS results and validations
• Root cause analysis and CAPA definition for deviations
• Collaboration in cross-functional teams including supply chain management
• Contributing to QTAs with partners, contract manufacturers and laboratories
• Participation in audits and inspections and assessment of GMP developments
• Driving process improvement initiatives to increase efficiency and strengthen compliance
• Key contact for regulatory authorities, customers and internal stakeholders on batch release and quality matters

Skills

Quality assurance

Regulatory compliance

Batch release

GMP knowledge

Cross-functional collaboration

German fluent

English fluent

Education

Pharmacy degree

Sachkundige Person §15 AMG

Chemistry degree

Job description

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