Senior Specialist - Method Lifecycle & QC Pharma Compliance
On-siteBudapest, Budapest, Hungary
Job Summary
Contribute to new product implementation and QSB-related change control processes while supporting method transfers, validation, and verification activities for APIs and final dosage forms. Lead monitoring and reporting of compendial updates globally, adapt pharmacopoeial methods, and prepare transfer documentation including protocols and reports. Act as the key contact for method-related quality activities across Xellia sites and communicate directly with CMO partners and strategic external stakeholders. Resolve complex global analytical issues, guide deviation and OOS investigations, and manage QC laboratory projects in collaboration with cross-functional teams. Initiate workflow optimizations to strengthen GMP compliance and provide coaching and mentoring to experienced colleagues.
Required Qualifications
- Minimum 10 years of experience in analytical chemistry or a related pharmaceutical analytical environment
- Expert-level, specialized knowledge in analytical methods and pharmaceutical quality control
- Strong experience in method transfers, validation, verification
- Advanced proficiency in English, both written and spoken
- The ability and willingness to share expertise, coach others and contribute to the development of global processes and best practices
Desired Qualifications
- A proactive, solution-oriented mindset and the ability to work independently on complex topics
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