AS&T Expert

2 days ago

Hyderabad, Telangana, India Sandoz Full time
Job Description

- 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.

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