Sachkundige Person / Qualified Person Für Klinische Prüfpräparate, Schwerpunkt Parenterale Darreichungsformen (bulk Drug Substance Und Bulk Drug Product) (all Genders) (vollzeit, Unbefristet)

Qualified Person For Clinical Trial Products

Herzlich willkommen bei AbbVie! As part of an international company with over 48,000 employees worldwide and around 3,000 employees in Germany, you have the opportunity to work closely with us to master the health challenges of tomorrow. Do you have a passion for improving healthcare around the world? Do you want to use your expertise to improve the quality of life for patients? In a challenging work environment that offers you the opportunity to expand and develop your own skills? Then you are right here with us!

Shape the future of clinical trial products as a Qualified Person (QP) with a focus on parenteral dosage forms (bulk drug substance and bulk drug product). In a modern, dynamic environment, you ensure the highest standards and innovative process optimization through active quality management, consistent compliance, and close teamwork.

Responsibilities:

• Exercising the function as Qualified Person (QP) / knowledgeable person in accordance with legal and regulatory requirements (e.g., AMG, AMWHV, EU GMP guideline, CTR No 536/2014)
• Responsibility for the production, testing, and marketing of clinical trial products, including imported products, both internally (pilot plant) and externally (TPM/TPL), with a focus on aseptically manufactured dosage forms (drug product)
• Ensuring compliance with legal requirements, conformity with IND/IMPD submissions, and product quality/safety
• Review, approval, and processing of production and testing-related documents, including deviations, OOS, and validations
• Processing and approval of deviations including root cause analysis, pharmaceutical assessment, and determination of CAPA measures
• Development and approval of specifications for active substances (drug substance) and bulkware (drug product)
• Collaboration in interdisciplinary product development teams (e.g., CMC teams, supply chain management) and expert support for bulkware
• Participation in quality assurance contracts (TQA) between AbbVie and partner companies, acquisitions, contract manufacturers, contract testers, and other service providers as well as other units and subsidiaries of AbbVie, ensuring compliance with contract contents and compliance
• Involvement in audits, inspections, and evaluation of new regulatory requirements and GMP situation in due diligence and in-licensing activities
• Leading initiatives and developing innovative concepts for process improvements to increase efficiency and improve compliance

Qualifications:

• Pharmacist with a successful university degree in pharmacy and approval as a pharmacist as well as knowledge as a knowledgeable person according to § 15(1) AMG necessary
• Several years of professional experience in the pharmaceutical industry in quality assurance, production, or testing of pharmaceuticals
• Competence in the quality assessment of active substances, knowledge according to § 15 Abs. 3a AMG for the release of active substances desirable
• Further education as a specialist pharmacist desirable (preferably pharmaceutical analytics, pharmaceutical technology, or pharmaceutical information)
• Very good knowledge of GMP (D, EU, US) and international pharmaceutical law
• Very good knowledge of the development, production, and testing of pharmaceuticals (focus on parenteral dosage forms)
• Profound analytical thinking with systematic analysis of complex situations to identify problems and effective problem-solving strategies
• Expert knowledge and leadership skills to lead a solution-oriented scientific-technical dialogue with management functions of different departments
• High degree of initiative and motivation as well as a team-oriented working style
• Profound ability for intercultural and cross-departmental cooperation as well as a network-oriented working style to build sustainable relationships with external parties (authorities, partners, customers)
• Clear, logical, and convincing communication of quality content in adjacent departments locally and globally, the global QA organization as well as partners and customers to develop suitable solutions and systems
• Basic knowledge of Lean Six Sigma and project management
• Very good German and English skills in speech and writing

How We Move Great Things Together

• With a diverse work environment where you can make a difference
• With an open company culture
• With an attractive compensation
• With an intensive onboarding including a mentor
• With flexible working models for a healthy work-life balance
• With an operational health management with comprehensive health and exercise programs
• With operational social benefits
• With diverse career opportunities in an international organization
• With high-level, attractive development opportunities
• With a strong, international network

We have been chosen multiple times worldwide as a "Great Place to Work" and are proud to offer our employees the flexibility that ensures a healthy work-life balance. We take our influence on the environment and society seriously and therefore focus on giving back regularly. We are committed to justice, equality, diversity, and inclusion (EEDI) – this is fundamental to us. This includes the appreciation of different perspectives, the creation of an inclusive culture, and the dignified and respectful treatment of all employees.

At AbbVie, your individual contribution counts – help us move great things together. Be part of our success and grow with us – and grow beyond yourself! Does this sound like the perfect career opportunity for you? Then we are looking forward to your application. All you need is a complete resume – everything else we will discuss personally with you.

Do you have any questions? Feel free to send an email to TalentAcquisition.de@abbvie.com – we look forward to your contact!