Quality Assurance – Clinical Services

3 days ago

Hyderabad, Telangana, India SafeVig Solutions Pvt Ltd Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Role Overview

As a Quality Assurance (QA) Associate/Executive, you will play a critical role in ensuring that SafeVig's clinical and pharmacovigilance operations adhere to global regulatory requirements (ICH-GCP, GVP, FDA, EMA, CDSCO). You will be responsible for internal audits, quality monitoring, SOP compliance, CAPA management, and supporting regulatory inspections.

This is an office-based position in Hyderabad.

Key Responsibilities

Develop, implement, and maintain Quality Management Systems (QMS) for clinical services and pharmacovigilance.

Plan, conduct, and document internal audits, vendor audits, and process reviews.

Ensure compliance with GxP, ICH-GCP, GVP, and other international regulatory requirements.

Manage SOP lifecycle – drafting, reviewing, updating, and training compliance.

Oversee CAPA (Corrective and Preventive Actions) – from initiation to closure.

Support regulatory inspections and client audits, ensuring inspection readiness at all times.

Maintain training documentation, deviation logs, risk registers, and QA trackers.

Collaborate with operations teams to ensure continuous process improvement and quality culture across the organization.

Provide QA oversight for projects, ensuring deliverables are compliant, consistent, and of high quality.

Required Qualifications & Skills

Education: Life sciences / Pharmacy / Clinical Research post-graduate degree preferred.

Experience: 4–5 years of QA experience in a CRO, Pharma, or Clinical Research/Pharmacovigilance organization.

Strong knowledge of ICH-GCP, GVP, FDA, EMA, and CDSCO regulations.

Hands-on experience in audits, CAPA, and QMS.

Excellent written and verbal communication skills.

Strong attention to detail, analytical thinking, and problem-solving ability.

Ability to manage multiple priorities and work effectively with cross-functional teams.

Why Join SafeVig?

Be part of a fast-growing, award-winning CRO that is reshaping pharmacovigilance and clinical services with technology.

Work alongside industry experts in an entrepreneurial, innovation-driven culture.

Opportunities for professional growth and exposure to global pharma & biotech clients.

Contribute directly to regulatory compliance, patient safety, and healthcare excellence.

How to Apply

Interested candidates can send their CVs to [insert email ID] with the subject line: Application – QA (Clinical Services).

Deadline: Applications open until the role is filled.

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