Munich Quality Assurance Specialist
Vor 6 Tagen
At Triga Consulting GmbH & Co KG, we're seeking a highly skilled Qualification Engineer to join our team in Munich. As a key member of our quality assurance department, you will play a vital role in ensuring the highest standards of quality and compliance within our biotechnology company.
About the RoleWe're looking for an experienced professional with a scientific education or university degree and at least 5 years of experience in the pharmaceutical industry. Your extensive knowledge of current GMP guidelines for equipment qualification, as well as your proficiency in validating computerized systems, will be crucial in this role.
- Your primary tasks will include planning and executing the qualification of equipment, devices, systems, facilities, and associated software.
- You'll conduct market research, obtain quotes based on requirement specifications, and independently prepare qualification documents.
- You'll perform risk analyses, derive necessary measures, and ensure their implementation, while also preparing SOPs and work instructions.
- You'll lead and organize qualification projects, including training employees on equipment operation, and ensure compliance with applicable regulations.
To succeed in this role, you'll need:
- A scientific education or university degree.
- At least 5 years of experience in the pharmaceutical industry.
- Extensive professional experience in equipment qualification and GMP-compliant documentation.
- Profound knowledge of current GMP guidelines for the qualification of equipment, devices, and systems.
- Experience in validating computerized systems in accordance with EU GMP Annex 11, 21 CFR Part 11, and GAMP 5.
- Meticulous attention to detail, a conscientious working style, and excellent teamwork skills.
- Initiative, commitment, high reliability, and independence.
- Service-oriented approach and focus on customer satisfaction.
- Language skills: German C1 - English B2.
In return for your expertise and dedication, we offer:
- An attractive salary range of approximately €60,000-€80,000 per year, depending on experience.
- Home office options: 1-2 days per week.
- A diverse and dynamic work environment.
- Flexible working hours (flexible working time models, 37.5 hours/week, home office).
- Variety of social benefits and opportunities for growth and development.
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