1. To implement and maintain procedures and systems to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with protocol, SOPs, Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and the applicable regulatory requirement(s).
2. To conduct study based, facility based, process based inspection/ audits.
3. To monitor the study activities: in all phases clinical, bio analytical, pathology, Statistical analysis and In-vitro etc.
4. To review data generated in clinical, analytical and statistical phase of the study.
5. To review protocol/ reports.
6. To monitor other activities such as but not limited to pathology, in-vitro, bio analysis, statistical etc.
7. To review general records such as but not limited to Calibration, maintenance, training etc.
8. To carry out vendor audits.
9. To review SOP(s). To prepare SOP(s) applicable to quality assurance department/ systems.
10. To follow document control, deviation control and change control.
11. To issue control records.
12. To maintain records such as but not limited to SMF, quality manual, list of SOP, instrument, etc.
13. To follow QA heads instructions and assist QA head.
14. Review of invitro validation and study data
15. Inprocess audit of validation /Study analysis
16. Daily checks of Laboratory Log Books and Calibration of instruments.
17. Review of Invitro SOP(s)
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: R&D
Role: Research Scientist
Employment Type: Permanent Job, Full Time