Senior Research Scientist - R&D

Job Description

1. Planning and resource allocation for routine operations of the analytical development function.
2. Ensure on time analysis of Finished products and raw materials for required product and projects.
3. Review of analytical data, raw data, daily usage logbooks and Lab notebooks for routine operations for analytical development function.
4. Preparation and review of critical documents like Analytical Method validation protocol, reports, Analytical method transfer protocols and reports.
5. Preparation and review of Standard operating procedures and their periodic review and updation.
6. Literature search and guide the Analytical development function for new method development.
7. To review data for stability studies and making sure samples are analysed on right time without any delays.
8. Identify the needs of resources of the analytical development function and initiate the procurement on right time to avoid delays in project deliverables.
9. To support the technology transfer of products to other destinations.
10. To ensure compliance of safety measures.
11. To raise change control for making any changes in system.
12. To ensure avoidance of breach of Data Integrity.
13. Ensure adherence to Good Manufacturing Practices (GMP)
14. Documentation related to Quality Management System/ Environmental Management System/ Occupational Health & Safety Assessment (ISO 9001:2015, ISO 14001:2015, OSAS 45001:2018).
15. To determine internal & external QEHS issues as well as needs and expectations of relevant interested parties & monitor the same.
16. To implement QEHS policy & objectives.
17. Ensure use of PPE in the departmental operations.
18. To identify & communicate incidents, QEHS non-conformities, investigate and take corrective actions on the same.
19. To ensure work permit system during maintenance activities.
20. To ensure proper disposal of waste.

Job Authority:

1. Review of analytical data for routine, stability and method validation and method transfer studies.
2. Planning and resource allocation
3. Preparation and review of Standard operating procedure.
4. Preparation & review of Technology transfer documents.
5. Review of calibration data.
6. Review of logbooks and Lab notebooks.
7. Identification and reporting of near misses, hazards & unsafe conditions.

Qualification - M. Sc.

M. Pharm

Job Description

1. Planning and resource allocation for routine operations of the analytical development function.
2. Ensure on time analysis of Finished products and raw materials for required product and projects.
3. Review of analytical data, raw data, daily usage logbooks and Lab notebooks for routine operations for analytical development function.
4. Preparation and review of critical documents like Analytical Method validation protocol, reports, Analytical method transfer protocols and reports.
5. Preparation and review of Standard operating procedures and their periodic review and updation.
6. Literature search and guide the Analytical development function for new method development.
7. To review data for stability studies and making sure samples are analysed on right time without any delays.
8. Identify the needs of resources of the analytical development function and initiate the procurement on right time to avoid delays in project deliverables.
9. To support the technology transfer of products to other destinations.
10. To ensure compliance of safety measures.
11. To raise change control for making any changes in system.
12. To ensure avoidance of breach of Data Integrity.
13. Ensure adherence to Good Manufacturing Practices (GMP)
14. Documentation related to Quality Management System/ Environmental Management System/ Occupational Health & Safety Assessment (ISO 9001:2015, ISO 14001:2015, OSAS 45001:2018).
15. To determine internal & external QEHS issues as well as needs and expectations of relevant interested parties & monitor the same.
16. To implement QEHS policy & objectives.
17. Ensure use of PPE in the departmental operations.
18. To identify & communicate incidents, QEHS non-conformities, investigate and take corrective actions on the same.
19. To ensure work permit system during maintenance activities.
20. To ensure proper disposal of waste.

Job Authority:

1. Review of analytical data for routine, stability and method validation and method transfer studies.
2. Planning and resource allocation
3. Preparation and review of Standard operating procedure.
4. Preparation & review of Technology transfer documents.
5. Review of calibration data.
6. Review of logbooks and Lab notebooks.
7. Identification and reporting of near misses, hazards & unsafe conditions.