Quality Assurance(Clinical Research)

1 week ago

Prahlad Nagar Ahmedabad Gujarat, India GSC Technolabs Private Limited(-For Clinvigilant Research Pvt. Ltd.) Full time

**Job description for the QA profile: -**

**Company: Clinvigilant Research Pvt. Ltd**

**Location: Ahmedabad(On-Site)**

**Position: 01 (One)**

**Experience: 03 + Years.**

**Job description:

- **
- **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: ₹600,000.00 per year

**Benefits**:

- Flexible schedule
- Provident Fund

Schedule:

- Day shift
- Monday to Friday

Supplemental Pay:

- Performance bonus

Ability to commute/relocate:

- Prahlad Nagar, Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Bachelor's (required)

**Experience**:

- Quality assurance: 3 years (required)

**Language**:

- English (preferred)

**Location**:

- Prahlad Nagar, Ahmedabad, Gujarat (required)

Willingness to travel:

- 25% (preferred)

Work Location: In person

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