AS&T Expert - Quality Operations

• Coordination and management of analytical method transfers and stability studies. Compilation of data reports.
• Compilation of Quality control monographs describing test procedure and specification setup.
• Scientific analytical support for quality control, production, registration, marketing.
• Presentation and discussion of analytical data in local and international project teams.
• Life-cycle management of analytical methods, including control of method performance, pharmacopoeia
• and health authority compliance and definition of method improvements. Handling of deviations,
• investigation, OOS/OOE/OOT cases as well as changes and complaints.
• Cross-functional interface with Manufacturing Science & Technology team, analytical development, production and regulatory department.
• Management and coordination of analytical activities at external laboratories (CROs). Support for trouble shooting activities and continuous improvement initiatives.
• Implementation of GMP requirements. Compilation and Review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents (Common Technical Document modules)).
• Budgeting and cost control of external analytical activities.
• Contribution to QC/AS&T network teams.
• Management of reference substances and control samples.

Essential Requirements:

• Minimum 10 years in pharmaceutical industry and/or analytical laboratory in GMP environment. MS Office- and other standard IT applications.
• External orientation: proactive communication, collaboration and exchange with PUs and SUs within local organisation and Novartis organisation.
• Innovation: continuously thrives for improvements and questions processes and procedures for improvements.
• Reacts in a flexible and fast way on changes and challenges.
• Ability to analyse complex processes.

Desirable Requirements:

• Degree in Chemistry, Pharmacy, Biology, Engineering or another related science.
• Language proficiency: English, German optionally.