Quality Assurance

15 hours ago

Mumbai Maharashtra, India Rusan Pharma Ltd Full time

**Roles & Responsibilities:

- **

1. To implement, manage and ensure the functions of GCP/ GLP Quality Assurance program that will assure all BA/BE studies and clinical studies to withstand regulatory scrutiny.

2. Assist to manage GCP/ GLP inspections of different regulatory bodies like USFDA, WHO, ANVISA etc. and second party sponsor audits.

3. Generation, distribution, retrieval and archival of SOPs of QCPL and maintenance of related records/logbooks/master list of SOPs.

4. Archiving the study and system related documents and electronic data generated at QCPL (As per OECD guidelines/ applicable regulatory guidelines/ current in house SOP).

5. Developing and implementing quality assurance plans for clinical and bioanalytical studies.

6. Conducting regular audits to ensure compliance with regulatory standards and protocols.

7. Reviewing of documentation related to clinical study, such as study protocols, case report forms, and consent forms etc.

8. Reviewing of documentation related to Bioanalytical study, such as method SOPs, Sample analysis plan etc.

9. Conduct the vendor or third party onsite and offsite audits.

10. Ensure all clinical trials and procedures are compliant with good clinical practices (GCP), applicable sops and guidelines.

Schedule:

- Day shift

Work Location: In person

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