A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Associate Scientist 1
Job Description
Position Purpose
Perform stability administration activities for packing , loading and pulling of the stability samples - drug substances (DS), drug products (DP) , follow processes and procedures in collaboration with a multifunctional project team coordinated by Project Leader. Contribute to maintenance of lab instruments/infrastructure.
Major Accountabilities
1. Act as system owner for Stability chamber
2. Responsible for periodic qualification & calibration, monitoring and maintenance of Stability chamber.
3. Designated as Stability Administrator for ARD IN
4. Responsible for GLIMS stability administration & IMA
5. Responsible for DS & DP packaging 6. Reviewer of Drug product packaging documents, drug substance packaging documents, calibration reports, re-qualification reports.
7. Review of CSA related documents.
8. Meet quality, quantity and timelines in all assigned projects. (I)
9. Perform and document stability admin activities.
10. Plan activities in collaboration with experienced team members if necessary. Seeks proactively for support and coaching from Project Leader or Scientific Expert/or other team members during the whole process if necessary. (I)
11. Provide documentation of activities to evaluate and contribute to interpretation of results – if necessary. (I)
12. Optimize existing processes . (I)
13. Actively support the initiation of the technical, registration and clinical stability studies (I)
14. Communicate problems, perform safety and literature searches under guidance from more experienced team members. (I)
15. Address simple problems. (I)
16. Keep record of packaging materials, samples within own area of responsibility. (I) 17. Collaborate with other team members to facilitate deliveries of DS and/or DP stability studies. (I) 11.Schedule and perform routine maintenance and calibration of lab instruments/equipment. (I)
18. Co-ordinate with the service providers to ensure timely calibration of lab instrument/equipment.
19. Actively contributes to team goals. (I)
20. Ensure all own activities are aligned with overall drug development process. (B)
21. Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISEC & Novartis Guidelines. (N)
Key Performance Indicator
1. Adherence to quality, quantity and timelines for all assigned tasks.
2. Adherence to Novartis standards, in particular, quality, ethical, health, safety, and environment standards (HSE), and information security standards (ISEC.
3. Ensures reproducibility of experiments and results.
4. Refer to annual individual and team objective setting
Candidate Profile
• M.Pharm/M.Sc./M.Tech Adequate knowledge of English (oral and written).
• Minimum of 3 years of relevant experience
• Awareness for safe handling of chemicals, potentially dangerous materials and equipment.
• Adequate scientific or technical knowledge in a spe-cific area (e.g. synthetic, analytical).
• Adequate knowledge of laboratory and/or technical tools.
• Good knowledge of software and computer tools.
• Basic presentation skills.
• Good communication skills
Additional Information
Experience : 3 years
Qualification : M.Pharm/M.Sc./M.Tech
Location : Hyderabad
Industry Type : Pharma
Functional Area : Global Drug Development
End Date : 15th September, 2018
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