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AS&T Expert - Quality Operations
Sandoz
posted 2mon ago
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Flexible timing
Key skills for the job
Job Description
Job Description Summary
The Analytical Science and Technology (AS&T) Expert is responsible for coordination and management of analytical activities of commercialized products as well as to provide scientific analytical support. About the Role:
The Analytical Science and Technology (AS&T) Expert is responsible for coordination and management of analytical activities of commercialized products as well as to provide scientific analytical support.
Key Responsibilities:
- 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.
Skills Desired
Continuous Learning, Dealing With Ambiguity, Employee Performance Evaluations, Gmp Procedures, People Management, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological IntelligenceEmployment Type: Full Time, Permanent
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based on 382 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Sandoz Benefits
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Competitive compensation Pay equity Pay for sustainable performance Differentiated benefits and wellbeing programs Values & integrity Balanced rewards
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