(Senior) Consultant GMP

Granzer Pharmaceutical Services GmbH was founded in 2022 as a spin-off of Granzer Regulatory Consulting & Services GmbH. We are a Pharmaceutical Service Provider and Consultancy for the Development, Manufacturing and Quality Assurance of Medicinal Products. Our focus is the EU Import, Storage, Distribution and EU-Release of Investigational Medicinal Products, supporting the Clinical Trials of our Clients.

For our team in Munich, we are looking for a

Responsibilities

• Provide expertise and consulting on GxP-related items to our clients
• Provide QA services to our clients
• Advise our clients in vendor selection and qualification activities
• Support the import and batch release processes for client IMP
• Support clinical distribution activities
• Support and/or perform GMP/GDP audits
• Support inspections by authorities, client audits and self-inspections
• Support and continuously improve our Pharmaceutical Quality System
• Support internal QA activities

Qualifications

• Academic degree as a pharmacist or degree in a Life Science related field
• At least 10 years of experience in the pharmaceutical industry with relevant experience for the position (e.g. Quality Assurance, Quality Control, Production)
• Excellent knowledge of GMP/GDP regulations in Europe and US
• Qualification as Qualified Person (according to Art. 49 of Directive 2001/83/EC) would be a plus
• Experience as auditor would be a plus
• Strong teamwork ethic and sound organizational skills for functioning with a high degree of independence on projects with minimal supervision
• Flexible, scientific working style and willingness for continuous education
• Willingness to travel (e.g. audits, meetings with clients and CDMO)
• Fluency in English; German would be a plus

A dynamic and friendly atmosphere with flexible working hours, working with highly motivated professionals and with international clients. Opportunities to develop and grow personally, to get exposure to a multitude of exciting projects and to contribute to the development of a growing organization. A culture of independent thinkers embracing debate and initiative.

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