Job Title: Quality Assurance Associate
Location: Gurugram, India (Hybrid Work Model)
Job ID: 25105204
Employment Type: Full-Time
Industry: Clinical Research | Pharmaceutical Quality Assurance | CRO | GxP Compliance
Syneos Health is hiring a Quality Assurance Associate to support audit management, regulatory inspection readiness, and enterprise quality management system (eQMS) operations at its Gurugram location. This hybrid role provides structured exposure to global clinical research quality frameworks and pharmaceutical compliance standards.
As a fully integrated biopharmaceutical solutions organization operating across 110+ countries, Syneos Health partners with leading pharmaceutical and biotechnology companies to accelerate clinical development and regulatory success.
The Quality Assurance Associate plays a critical role in supporting internal audits, customer audits, and regulatory inspections by ensuring accurate documentation, audit tracking, and compliance data management. The position contributes directly to maintaining GCP, GxP, and global regulatory compliance standards within a CRO environment.
This opportunity is well-suited for professionals aiming to build expertise in:
Clinical Quality Assurance (CQA)
Pharmaceutical Compliance & Regulatory Affairs
Audit Coordination & Inspection Readiness
Enterprise Quality Management Systems (eQMS)
CRO Quality Operations
Assist in tracking scheduled and planned audits within the enterprise quality management system.
Update audit schedules and compliance calendars as directed by QA leadership.
Support audit preparation activities by compiling required documentation such as:
Training records
Organizational charts
Standard Operating Procedures (SOPs)
Quality and compliance records
Assist auditors in gathering follow-up information during customer audits and regulatory inspections.
Enter and maintain accurate audit-related data in the eQMS.
Maintain, file, and archive Quality Assurance documentation in accordance with internal policies and regulatory standards.
Ensure proper document control, version tracking, and record retention.
Assist in preparing QA tools, trackers, and compliance documentation.
Support ongoing inspection readiness initiatives across departments.
Perform other QA-related tasks as assigned.
Work under structured supervision with detailed instructions for day-to-day tasks.
Minimal travel may be required (up to 25%).
0–2 years of experience in healthcare, pharmaceutical, biotechnology, or clinical research settings.
Exposure to quality systems, regulatory documentation, compliance processes, or audit support is preferred.
Fresh graduates with relevant internships in QA, clinical operations, or regulatory functions may be considered.
Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Healthcare Management, or a related discipline.
Equivalent combination of education and relevant professional experience may be considered.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Basic knowledge of SharePoint or electronic document management systems preferred.
Strong organizational and multitasking skills.
Ability to manage deadlines in a dynamic, compliance-driven environment.
Excellent written and verbal communication skills.
Strong attention to detail and documentation accuracy.
Cultural sensitivity and ability to collaborate effectively with global stakeholders.
Hybrid work model based in Gurugram, India.
Exposure to global pharmaceutical and clinical research compliance operations.
Structured corporate quality framework with defined career growth opportunities.
Inclusive and collaborative professional environment.
This role provides foundational experience in:
Enterprise Quality Management Systems (eQMS)
GCP and GxP regulatory standards
Audit preparation and regulatory inspection processes
Clinical research compliance documentation
Potential future roles include:
Clinical Quality Assurance Specialist
QA Auditor
Regulatory Affairs Associate
Quality Systems Analyst
Syneos Health is a global biopharmaceutical solutions organization that has supported 94% of novel FDA-approved drugs and 95% of EMA-authorized products over the past five years. With more than 29,000 employees worldwide, the company collaborates across thousands of clinical trial sites to advance medical innovation.
If you are seeking to start or advance your career in Pharmaceutical Quality Assurance, Clinical Compliance, or Audit Support, this hybrid opportunity in Gurugram offers strong exposure to global regulatory standards within a leading CRO environment.
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