Quality Assurance

2 weeks ago

Bengaluru Karnataka, India MS CLINICAL Full time

**Job Title: Quality Assurance (QA) - Clinical Research**

Experience: 8-10 years

Location: Indiranagar, Bangalore

Department: Quality Assurance

**About the Role**

**Key Responsibilities**
- Develop and maintain ICH/GCP-compliant processes to control the quality of work and clinical studies at MSCR.
- Lead and manage internal quality audits, CAPA activities, and quality management reviews.
- Conduct study audits to ensure adherence to sponsor protocols, GCP, industry guidelines, and regulatory requirements.
- Identify non-conformances, recommend corrective measures, and drive risk-based continuous quality improvements.
- Perform vendor audits, collaborate with vendors and production support teams, and implement root cause analysis techniques to strengthen product quality.
- Deliver training sessions to MSCR staff on QA processes, compliance, and best practices.
- Support the review, evaluation, and implementation of new technology products and equipment.
- Review vendor-supplied data and quality records to ensure compliance with documentation standards.
- Provide QA expertise in special projects as required by management.
- Perform other QA-related duties as assigned.

**Requirements**:

- 8-10 years of experience in Quality Assurance within clinical research, pharmaceuticals, or life sciences.
- Strong knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
- Proven experience in internal and external auditing (including vendor audits).
- Experience in CAPA management and quality risk management methodologies.
- Ability to conduct root cause analysis and implement sustainable solutions.
- Strong understanding of Good Documentation Practices (GDP).
- Excellent communication, presentation, and training skills.
- Ability to work cross-functionally and manage multiple stakeholders.

**Preferred Qualifications**
- Prior experience in a clinical research organization (CRO) or clinical trial QA environment.
- Experience in handling regulatory inspections.
- Knowledge of electronic systems used in clinical QA.

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