At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
QA Regulatory Compliance Expert (m/w/d)
YOUR TASKS AND RESPONSABILITIES
- Participation in a program for product transfer with a new technology
- Ensuring proper compliance of all registration dossiers at the site in the role of site supervisor
- Drafting, preparation and approval of technical registration documents
- Evaluating change controls for their impact on the registered dossier
- Conducting regulatory gap assessments and compliance reviews
- Initiating appropriate actions to investigate and follow up on CAPA corrections in the local quality system
- Function as the main point of contact for domestic and foreign health authorities and agencies for all inquiries
- Independently preparing work instructions for business processes and systems
- Participating in internal and external audits and inspections
WHO ARE YOU
- Completed studies in pharmacy, natural sciences or a similar qualification (MSc, state examination or doctorate)
- Several years of experience in the pharmaceutical or chemical industry, preferably in a regulatory affair or GxP quality assurance function
- Knowledge of MS Office applications; SAP knowledge an advantage
- High affinity and interest in document creation and handling, as well as navigating document management systems
- Attitude towards improvement towards more efficient processes and better ways of working
- Attention to detail and good analytical skills to grasp and solve complex problems
- Independent and results-oriented approach to work, high motivation and team spirit
- Excellent communication skills in English and German are required
YOUR APPLICATION
This is your opportunity to tackle the world’s biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Location: Bitterfeld-Wolfen
Division: Consumer Health
Reference Code: 786540