Job Title: Associate Scientist - DPD
Competencies
Purpose of Job
Skill Required
Roles and Responsibilites
1. To support in planning, executing, & performing various drug product development studies and bio-similarity studies.
2. Writing protocols and reports for various drug product development studies
3. To support in process and technology transfer related documentations.
4. To support in executing the stability studies and preparing reports for same.
5. Getting trained on batch manufacturing procedure for drug product and do related documentation.
6. To get trained on HPLC and CE techniques and perform analysis of stability samples.
7. Response to DQA observations and closure of reports.
8. Preparing and updating of SOPs.
9. Ensuring the calibration of the equipment as per the schedules.
10. Attending necessary trainings and following compliance.
11. To follow ‘Good Documentation Practices and Data Integrity’ requirements during any GxP Operation and recording at site.
12. To take responsibility that application of Data Integrity requirements and potential consequences for not following it are understood and followed.
13. To review in the perspective of compliance to Data Integrity requirements while reviewing any GxP data (Records, Reports) specific to Job description.
Qualification Required
Relevant skills / Industry experience
Relevant professional / Educational background
Any other requirements (If any)
Compensation / Reward
Biotech, Ahmedabad, GJ, IN, 382213