Quality Assurance Deputy/Responsible Person
Join our effort to make a difference to patients all over Europe …
Macure Pharma is an international pharmaceutical company with primary focus on niche hospital products for the European Market.
We have a solid network of CMOs and pre-wholesalers/ distributors across Europe, which provides us with a very flexible and scalable business structure. We are privately owned, which ensures our employees influence and quick decision-making processes.
Macure Pharma is experiencing a steep growth and have a very strong pipeline, we are therefore strengthening our organization in strategic locations across Europe. One of these locations is Malta, where our new QA Deputy will be located.
The Macure HQ is located in Denmark. As QA Deputy you will work closely together with both external stakeholders and your Danish colleagues on an everyday basis with report to the QA Manager. As our first colleague in Malta, you must thrive on working independently and have a true “can-do attitude”. You will play an important role in building up Macure Pharma and get into a young dynamic organization with highly skilled colleagues and a “freedom with responsibility-culture”.
THE JOB:
Your main tasks will be to:
• Manage Macure Medical Information
• Develop and maintain our Quality Management System
• Develop and improve quality related procedures
• Perform GDP training of Macure Personnel
• Manage Deviations & CAPAs
• Manage Complaints
• Approve and handle Change Controls
• Perform Customer Qualification and Re-qualification
• Perform Supplier Qualification and Re-qualification
• Host audits of Macure Healthcare Ltd.
• Participate in external audits of Macure Partners
• Host and perform self-inspections
YOUR PROFILE:
We are looking for candidates with:
• M.Sc. Pharm. Degree or other relevant background
• +2 years of experience with QA related tasks
• Being registered as Responsible Person with the Malta Medicines Authority is regarded an asset
• Solid project management skills and experience with process development
• Ability to work independently and coordinate several tasks at a time
• Excellent level of oral and written communication skills in English
• Ability to travel occasionally
HOW TO APPLY
Interviews are conducted currently, so please submit your application as soon as possible. Application and questions can be directed to HR Business Partner, Lotte Tolstrup, mail: job@macurepharma.com, phone: +45 40329734. We look very much forward to receiving your motivated application and CV.
For further information, please refer to our homepage www.macurepharma.com.