Quality Assurance Auditor

**Job Summary**

We are seeking a Quality Assurance Auditor 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) Conduct audits and assessments of the CRO's systems, processes, and documentation to ensure compliance with Good Clinical Practice (GCP) guidelines, applicable regulatory requirements, and company SOPs (Standard Operating Procedures).

2) Plan and execute internal and external audits, including vendor audits, investigator site audits, and process audits, to assess the quality and integrity of data, adherence to protocols, and compliance with regulations and guidelines.

3) Evaluate essential trial documentation, such as study protocols, informed consent forms, case report forms, and clinical trial reports, to ensure accuracy, completeness, and compliance with regulatory requirements.

4) Identify non-compliance issues and deviations during audits and investigations and work with cross-functional teams to develop corrective action plans (CAPAs) and ensure their timely implementation.

5) Risk Assessment: Conduct risk assessments to identify potential quality and compliance risks associated with clinical trials and research activities, and collaborate with stakeholders to develop risk mitigation strategies.

6) Training and Education: Provide guidance and training to CRO staff on quality systems, regulatory requirements, and best practices to foster a culture of quality and compliance.

7) Stay up to date with relevant regulations, guidelines, and industry best practices related to clinical research, and provide support in interpreting and implementing regulatory requirements.

8) Develop and maintain quality metrics to monitor the effectiveness of the CRO's quality management system, and generate reports on audit findings, compliance status, and quality indicators for management and regulatory authorities.

9) Proactively identify opportunities for process improvement and efficiency gains within the CRO's quality management system, and contribute to the development and enhancement of quality-related policies, procedures, and guidelines.

10) Prepare the CRO and its stakeholders for regulatory inspections by conducting mock audits, ensuring inspection readiness, and providing guidance during inspections to address any findings or observations.

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

2. At least 05 - 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, Regular / Permanent

**Salary**: From ₹600,000.00 per year

**Benefits**:

- Health insurance

Schedule:

- Day shift
- Monday to Friday

Ability to commute/relocate:

- Gandhinagar, Gujarat: Reliably commute or willing to relocate with an employer-provided relocation package (preferred)

**Education**:

- Master's (preferred)

**Experience**:

- Quality assurance (preferred)
- QA auditor (preferred)
- 05 - 08 Years of QA auditor (preferred)

**Language**:

- English (preferred)

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