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Hod - Quality Assurance

3 months ago

Gandhinagar, India Eccentric Clinical Research Pvt Ltd Full time

**Job Summary**

We are seeking a HOD - Quality Assurance to join our reputable Contract Research Organization (CRO) and be responsible for ensuring the highest standards of quality and compliance in our clinical research activities. In this crucial role, you will play a key part in maintaining regulatory compliance, conducting audits, and driving continuous improvement efforts. Additionally, as a member of our Quality Assurance team, you will contribute to the overall success of our organization by providing exceptional support to our clients and stakeholders.

**About Us**

We are a comprehensive Clinical Research Organization that offers a complete range of services to sponsors, covering every aspect from protocol development to the final submission of Clinical Study Reports (CSRs). The Eccentric Clinical Research is a trusted firm that specializes in providing clinical research services within India. Our extensive service portfolio includes clinical operations, site monitoring, data management, regulatory affairs, medical writing, and quality assurance. As experienced clinical research consultants, we assist our clients with proficient management of their clinical research projects and expert regulatory guidance. From project proposal evaluation to the successful completion of clinical trials, including necessary clearances and documentation, we provide continuous support and guidance to our clients at every stage of their projects.

**Job Description**:
1. Primarily responsible for Quality Assurance Activities during the clinical trial study. Ensure clinical trials are conducted in accordance with the study protocol and in compliance with different regulatory requirements.

2. Effective implementation of QMS.

3. Set department objectives and monitor ongoing progress and performance in a timely manner.

4. Plan, manage, and conduct internal audit, external Audits, and Vendor Audits.

5. Develop a GCP-compliant SOP system and Document Management System.

6. Develop Quality Assurance SOPs and review other department’s SOP as per GCP and different regulatory requirements.

7. Develop, train and mentoring the Quality Assurance team to perform different functions of the Quality Assurance department

8. Ensure that CAPAs are delivered, and non-compliances are reported on time.

9. Ensure strong communication between teams under leadership to facilitate the exchange of information and in order to implement change and improvements.

10. Work collaboratively and engage with key internal and external stakeholders to facilitate compliance with quality strategy and ensure optimal performance.

11. Contribute to new business initiatives and projects.

12. Report on Quality Activities on a regular basis to the senior management, ensuring accurate and timely reporting of the relevant key performance indicators. Planning and conducting of management review meeting.

13. Reviewing deviation and change control and effective implementation of CAPA.

14. Management and proper documentation of any incident that occurred in the organization. Review investigation reports and lead in the impact analysis and evaluation of CAPA.

15. Preparatory work for regulatory inspections/sponsor’s Audit, presenting the quality system during audit and inspections and responding to the observations or non-compliance and implementation of CAPA on a timely manner.

16. Interviewing and selecting new employees and developing and evaluating existing employees for QA department.

17. Prepare the annual quality budget and forecasts and capital expenditure proposals as well as manage the budget from initiation to completion of projects.

**Qualifications & Required Skills**:
1. Pharm D/ M. Pharm/ B. Pharm / bachelor’s degree in Life Sciences

2. More than 08 years of previous experience in CRO Operations / Pharma Industry.

3. Strong knowledge of GCP guidelines and relevant regulatory requirements (e.g., FDA, EMA).

4. Experience in conducting audits and assessments in the clinical research field.

5. Excellent attention to detail and analytical skills.

6. Strong communication and interpersonal skills to effectively collaborate with cross-functional teams.

8. Ability to work independently, prioritize tasks, and manage multiple projects simultaneously.

9. Problem-solving skills and the ability to propose practical solutions to compliance issues.

Familiarity with quality management systems and quality improvement methodologies

**Job Types**: Full-time, Permanent

**Salary**: From ₹1,000,000.00 per year

**Benefits**:

- Health insurance

Schedule:

- Day shift
- Monday to Friday

**Education**:

- Master's (preferred)

**Language**:

- English (preferred)

Ability to Relocate:

- Gandhinagar, Gujarat: Relocate before starting work (required)

Willingness to travel:

- 25% (preferred)

Work Location: In person

Expected Start Date: 26/02/2024