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AS&T Expert - Quality Operations
ConfidentialHyderabad / Secunderabad, Telangana30+ days ago
Job descriptionCoordination 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.
- Degree in Chemistry, Pharmacy, Biology, Engineering or another related science.
- Language proficiency : English, German optionally.
Desirable Requirements :
Skills Required
data compilation, Troubleshooting, stability studies
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Operation • Hyderabad / Secunderabad, Telangana
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