Sandoz continues to go through an exciting and transformative period as a integral leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. As part of our Quality team you will manage quality aspects and projects within area of responsibility. You will also ensure and support overall GxP conformity and Compliance with the Sandoz Quality Management Systems.
Responsibilities
- Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance Support exception investigations
- Review and approval of production, QC, and AS and T records
- MBR review
- Executes batch release in compliance with registration
- Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt
- Distribution of marketing samples (where applicable)
Key Performance Indicators
- On-time and GMP-compliant release of dosage forms
- No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand
- Successfully support continuous improvement projects
- Executes batch release in compliance with registration
Qualifications
- QC/ QA in pharmaceutical industry / biotech with environmental monitoring.
- Collaborating across boundaries.
- Cleanliness zones.
- Continuous Learning.
- Dealing with Ambiguity.
- GMP Procedures.
- QA (Quality Assurance).
- Quality Control (QC) Testing.
- Quality Standards.
- Self-Awareness.
- Technological Expertise.
- Technological Intelligence. xqbhyrx
- English – fluent reading and speaking.