Regulatory Compliance Specialist Role

6 days ago


Bengaluru, Karnataka, India Emmes Full time
The Senior Quality Assurance Specialist is responsible for ensuring the quality and integrity of clinical trials conducted by Emmes. This involves conducting regular audits, identifying and addressing non-compliance issues, and collaborating with cross-functional teams to ensure effective implementation of quality management systems and regulatory requirements.

Responsibilities

- Conduct regular audits of projects, processes, and clinical sites to ensure compliance with regulations and industry standards.
- Identify and address non-compliance issues, develop corrective action plans, and track progress towards resolution.
- Develop and implement procedures for managing change controls, deviations, and other quality-related activities.

Requirements

- Bachelor's degree in Life Sciences or a related field, or equivalent experience in Clinical QA or CSV QA.
- At least 4 years of related experience, or 6+ years in a regulated environment (e.g., GxP, ISO).
- Strong understanding of SDLC validation tools and testing strategies like SAST and DAST.
- Excellent communication and leadership skills, with the ability to work effectively in a fast-paced environment.

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