[Diese Stellenausschreibung ist nur auf Englisch verfasst, da für diese Position fließende Englischkenntnisse unbedingt erforderlich sind.]
AqVida is a pharmaceutical company specializing in the development, registration, manufacturing, and distribution of oncology products. Our portfolio includes key generics used in the treatment of the most common cancer types. While our customers are located globally, we have two sites in Northern Germany: since 2005, our headquarters in Hamburg, and our state-of-the-art production facility in Dassow, Mecklenburg-Vorpommern, inaugurated in 2016.
Preferably for our office in the heart of Hamburg, we are looking for a dedicated "Production Compliance Manager (f/m/d)" starting in December 2024. The role is responsible for maintaining and updating our manufacturing instructions (Master Batch Records, MBR) and ensuring compliance with GMP guidelines.
Your Responsibilities:
- Maintenance and updating of the Master Batch Records, Batch Records, and Quality Assurance Agreements (QAA) in accordance with market authorizations and GMP
- Supplier qualification: Managing approved supplier lists, audit coordination, and preparing audit reports
- Change control communication
- Management and maintenance of stability data
- Close collaboration with various internal and external stakeholders to ensure quality and compliance in production
Your Profile:
- Degree in pharmacy, chemistry, biology, physics, or a related field, or relevant training (apprenticeship) in the pharmaceutical industry
- Professional experience in project planning, coordination, and communication
- Professional and positive approach, team-oriented, dynamic, and energetic
- Proficiency in English, both written and spoken; German is desirable but not required
We offer:
- Flexible working hours: The scope of the position can be adjusted; therefore, this role can be performed part-time (ranging from 25 to 40 hours per week); we also offer flexible working hours by arrangement
- For optimal work-life balance, we offer more vacation days than legally required (e.g., 30 vacation days per year for a 5-day workweek)
- Employees can receive bonuses tied to the company’s success
- Access to company pension schemes or capital-forming benefits
- A diverse and welcoming team: Our company includes employees from over 20 nationalities, all age groups, and various professional backgrounds
- Want to be at the pulse of the city? Our central Hamburg location ensures you’re always in the midst of action. During breaks, enjoy a range of global cuisine just a few minutes away. Gänsemarkt is only a 5-minute walk, and the Alster is reachable within 10 minutes. On rainy days, feel free to use our fully equipped kitchen
If this sounds like you and you enjoy a fast-paced, direct work style in an unconventional pharmaceutical company, please send your resume, certificates, salary expectations, and start date (we care about your skills, so no cover letter required) as a PDF in one file (max 3 MB) to bewerbung@aqvida.com.