QA In-charge

QA In-Charge (Late Phase)

The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback.

Responsibilities

1. Review and maintain QMS documents like SOPs, Change control, deviations, events.

2. Responsible for conducting Internal/External audits (i.e., Investigator site audits) for Clinical Trial Projects to ensure compliance with SOPs, Protocol, ICH GCP, quality system and applicable regulatory requirements.

3. Responsible for planning, conducting, and reporting of system audit of clinical trial, clinical data management, software development and Bio-stat departments.

4. Review study TLFs (Table, listing and figure)

5. Audit study database in various clinical data management systems.

6. Responsible for planning, conducting, and reporting of Vendor Audits to ensure compliance with study and/or Sponsor requirements and applicable regulatory requirements.

7. Review of study documents like study protocol, inform consent, eCRF, Data management plan, study plans, Statistical analysis plan (SAP), clinical study report, to ensure compliance, correctness and adequacy with ICH GCP and other applicable regulatory requirements.