Quality Assurance Manager (m/f/d)

Gulp Ag; Frankfurt; Presencial; EUR 70 000 - 110 000; Tempo integral

Resumo da oferta

Gulp AG in Frankfurt am Main is seeking a QA Manager to lead quality assurance efforts for APIs, intermediates, and raw materials in a compliant and efficient manner.

The role covers planning and evolving QA processes, batch release decisions, change controls, and audits of suppliers and contract manufacturers, with close collaboration across interdisciplinary teams and interactions with authorities during inspections.

Qualificações

• Completed university degree in biology, pharmacy, chemistry or an equivalent qualification.
• Several years of experience in quality management in the pharmaceutical industry.
• Comprehensive GMP knowledge.
• Excellent German and English skills, both spoken and written.
• Enjoyment of working together in interdisciplinary teams.

Responsabilidades

• Planning, evaluation, and further development of quality systems for APIs, intermediates, and raw materials to current scientific standards and legal regulations.
• Conducting quality tests, reviewing batch documentation, and deciding on the release or rejection of API batches.
• Implementing and being responsible for operational quality assurance systems, including handling changes and failure investigations.
• Reviewing and releasing manufacturing instructions, SOPs, validation/qualification documentation, and quality-relevant procedures.
• Designing and participating in process and cleaning validations, and monitoring product quality; preparing registration documents.
• Conducting audits of suppliers, contract laboratories, and contract manufacturers; representing the department in project teams, inquiries, and inspections.

Conhecimentos

Quality management

GMP knowledge

Interdisciplinary teamwork

German language

English language

Formação académica

University degree in biology, pharmacy, chemistry or equivalent

Descrição da oferta de emprego

Kickstart your career as a QA Manager! We have the perfect opportunity for you in the pharmaceutical sector: We are currently seeking a QA Specialist on behalf of our business partner for their Frankfurt am Main location. We'll open the door to this exciting position for you!

We value equal opportunities and welcome applications from people with disabilities.

Planning, evaluation, and further development of the chemical-pharmaceutical quality of active pharmaceutical ingredients (APIs), intermediates, and raw materials according to current scientific standards and legal regulations. Conducting quality tests, reviewing batch documentation (batch record review), and deciding on the release or rejection of API batches. Implementing and being responsible for operational quality assurance systems, in particular handling changes (change control) and failure investigations. Reviewing and releasing manufacturing instructions, standard operating procedures (SOPs), validation and qualification documentation, and quality-relevant procedures. Designing and participating in process and cleaning validations, defining critical process parameters, and continuously monitoring product quality. Ensuring inspection-ready, GMP-compliant documentation and the timely preparation of chemical-pharmaceutical registration documents. Preparing and conducting audits of suppliers, contract laboratories, and contract manufacturers to monitor quality standards, including participating in supplier selection. Representing the department in project teams, handling customer inquiries and complaints, and representing the company to authorities and during inspections.

• Completed university degree in biology, pharmacy, chemistry or an equivalent qualification
• Several years of experience in quality management in the pharmaceutical industry, preferably in active ingredient production
• Comprehensive GMP knowledge and didactic skills
• Excellent German and English skills, both spoken and written.
• Enjoyment of working together in interdisciplinary teams
• Flexibility, willingness to perform and resilience
• Strong sense of responsibility, assertiveness and quality-oriented action