AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care. To enhance our team in Vienna we are looking for an Associate Product Quality (f/m/d).
In this position, you’ll play a key role in ensuring superior product quality. You’ll manage critical documents, shaping our commitment to excellence and reliability, while contributing to a culture of continuous improvement and regulatory compliance.
What Your Day To Day Will Look Like
- Management and archiving of key documents, including comprehensive diagrams (product flow charts), manufacturing instructions, testing instructions, and product specifications for selected products (drug substance and drug product, as applicable)
- Creation, revision, and approval of packaging materials in the ERP database
- Compiling stability study and batch release data, as well as trending analysis of stability study and batch release data
- Support in the preparation of Annual Product Quality Reviews
- Preparation and maintenance of selected Standard Operating Procedures
- Incident management, including handling out-of-specification results, complaints, and deviations related to product quality
- Change control management for product quality-related changes
- Handling complaints related to product quality GMP Co Auditor (based on experience)
Your Qualifications and Experience
- Bachelor's degree in a relevant scientific discipline
- 2+ years professional working experience
- Strong understanding of quality management systems and regulatory requirements, preferably in the pharmaceutical industry
- Experience in managing and archiving key documents, along with proficiency in ERP systems is a plus Excellent analytical and problem-solving skills
- Ability to work effectively in a team environment and collaborate across departments
- Strong attention to detail and ability to multitask in a fast-paced environment
- Effective communication skills, both written and verbal Experience in GMP auditing is a plus Proficient in German and English
- Well-versed in Office 365
Our Offer
- Open corporate culture with the opportunity to bring in your own ideas
- Great opportunities for personal and professional development
- Attractive work environment with excellent career opportunities and flat hierarchies
- Competitive salary package plus bonus and various benefits
- Gross monthly salary provided for this function is a minimum of EUR 2.800.- based on full-time employment. Any potential overpayment depends on professional experience and qualifications.
