Job Description

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.

Qualifications and skills:

1. Minimum Bachelor's degree in Pharmacy or Life sciences.

2. Knowledge of GCP, ICH guidelines, ISO 9001:2015 quality management system, FDA regulations and other regulatory guidance for conducting bioequivalence and clinical trials.

Interested candidates share resume at bhavashree.patil@rusanpharma.com

Job Type: Full-time

Schedule:

• Day shift

Experience:

• total work: 2 years (Preferred)
• Quality assurance: 2 years (Preferred)
• Clinical research: 2 years (Preferred)

Work Location: In person