- Ensuring compliance: Ensuring that clinical processes are conducted in accordance with regulations and guidelines
- Managing quality assurance activities: Developing, performing, and managing quality assurance activities
- Conducting audits: Presiding over audits of investigators, vendors, facilities, and systems
- Preparing reports: Preparing annual reports, quality trending reports, and QC review reports
- Training staff: Coordinating training for new clinical research staff, and determining staff training requirements
- Maintaining databases: Managing and maintaining databases for the quality system
- Supporting clinical research operations: Assisting with the preparation for audits, and entering enrolments into databases
- Reviewing and approving SOPs: Reviewing and approving new SOPs, and modifications to existing SOPs
- Evaluating incidents: Evaluating quality events, incidents, queries, and complaints
- Communicating with regulatory agencies: Compiling and preparing materials for submission to regulatory agencies
- Developing a Quality Management System (QMS): Developing, implementing, and maintaining a QMS
QA professionals should have strong interpersonal and communication skills, and be knowledgeable in different areas. They should also have previous clinical research experience.
Job Types: Full time, Permanent
Pay: ₹25,000.00 - ₹35,000.00 per month
Ability to commute/relocate:
- Prahlad Nagar, Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (Required)
Application Question(s):
- Are you comfortable in suggested Salary Band?
- What is your notice period?
- How frequent you can join?
Education:
- Bachelor's (Required)
Experience:
- Quality assurance/ quality control: 3 years (Required)