Quality Assurance Auditor Clinical Research Gcp

2 days ago

Hyderabad Telangana, India QualiTlabs Full time

**Job description**:
A **Quality Auditor** is responsible for ensuring that all aspects of the Company’s Quality Management System adhere to regulatory standards and established quality guidelines. This role is crucial for maintaining the integrity of clinical trial data and protecting the safety of participants.

**Key Responsibilities**
- **Conducting/Host Audits**: Perform internal and host external audits. These audits verify compliance with Good Clinical Practice (GCP) guidelines, Good Documentation Practices (GDP), company standard operating procedures (SOPs), and other relevant regulations. Write up an audit report and track findings.
- **Quality Management**: Evaluate and help maintain the company’s quality management system (QMS). This includes reviewing quality events, incidents, and complaints to identify root causes and recommend corrective and preventative actions (CAPAs).
- **Documentation and Reporting**: Prepare detailed audit reports that document findings, non-conformities, and recommendations for improvement. Present these findings to senior management and work with various teams to ensure issues are resolved.
- **Regulatory Compliance**: Stay up to date with all applicable regulations and guidelines from bodies like the FDA and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Ensure that these regulatory requirements are communicated and implemented across the organization.
- **Training**: Ensure training compliance of quality assurance procedures, GXP guidelines (such as GCP), and the importance of a quality-focused approach.

**Required Skills and Qualifications**:

- **Analytical Skills**: Strong analytical and problem-solving abilities are vital for identifying discrepancies, evaluating data, and drawing logical conclusions from audit findings. Attention to Detail: The role demands a meticulous and detail-oriented approach to reviewing documents, data, and processes.
- **Communication**: Excellent written and verbal communication skills are necessary to clearly articulate audit findings and work collaboratively with diverse teams and stakeholders.
- **Knowledge of Regulations**: A thorough understanding of GCP, ICH guidelines, and other relevant clinical trial regulations are a fundamental requirement.
- **Certifications**: Certifications from professional bodies, such as the American Society for Quality (ASQ), can be advantageous.

**” Quality Auditor “**

**Role**: Quality Assurance - Other

**Industry Type**: IT Services & Consulting

**Department**: Quality Assurance

**Employment Type**: Full Time, Permanent

**Role Category**: Quality Assurance - Other

**Education**

**UG**: Any Graduate

**PG**: Any Postgraduate

**Experience**:3+yrs 5+yrs 7+yrs

**Job Type**:Full Time

**Job Location**:Hyderabad

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