Job Title: Quality Assurance Associate
Location: Gurugram, India (Hybrid Work Model)
Job ID: 25105205
Employment Type: Full-Time
Industry: Clinical Research | Pharmaceutical Quality Assurance | CRO | GxP Compliance
Syneos Health is seeking a motivated and detail-oriented Quality Assurance Associate to support audit tracking, regulatory inspection readiness, and enterprise quality management system (eQMS) activities. This hybrid opportunity in Gurugram is ideal for professionals looking to build a long-term career in clinical quality assurance, pharmaceutical compliance, and CRO audit operations.
As a globally recognized biopharmaceutical solutions organization operating across 110+ countries, Syneos Health plays a critical role in accelerating drug development and supporting regulatory approvals worldwide.
The Quality Assurance Associate supports internal and external audit coordination by managing documentation, maintaining audit schedules, and ensuring accurate data entry within the enterprise Quality Management System. The role contributes directly to maintaining regulatory compliance and inspection readiness across clinical research operations.
This position is particularly suited for candidates seeking growth in:
Clinical Quality Assurance (CQA)
GCP and GxP Compliance
Regulatory Inspection Support
Pharmaceutical Quality Systems
CRO Quality Operations
Track planned and scheduled audits within the enterprise quality management system (eQMS).
Update audit schedules and compliance calendars as directed by QA leadership.
Assist in preparing documentation for internal audits, customer audits, and regulatory inspections, including:
Training records
Organizational charts
Standard Operating Procedures (SOPs)
Compliance documentation
Support auditors by obtaining follow-up documentation during inspections.
Enter and maintain accurate audit-related records within the eQMS.
Maintain, file, and archive Quality Assurance documentation in accordance with company SOPs and regulatory requirements.
Ensure document accuracy, version control, and proper record retention.
Assist in the preparation of QA tools, trackers, and quality documentation.
Support inspection readiness initiatives across business functions.
Perform additional QA-related tasks as assigned.
Collaborate with cross-functional stakeholders across global teams.
Minimal travel may be required (up to 25%).
0–2 years of experience in healthcare, pharmaceutical, biotechnology, or clinical research environments.
Prior exposure to quality assurance, compliance documentation, audit coordination, or regulatory processes is preferred.
Candidates with relevant internships or academic project experience in QA or clinical operations are encouraged to apply.
Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Healthcare Management, or a related discipline.
Equivalent education and relevant professional experience may be considered.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Basic familiarity with SharePoint or document management systems preferred.
Strong organizational and time management skills.
Ability to manage multiple tasks and meet strict deadlines.
Strong written and verbal communication skills.
Cultural sensitivity and ability to collaborate with global stakeholders.
High attention to detail and documentation accuracy.
Ability to work effectively under structured supervision in compliance-driven environments.
Hybrid work model based in Gurugram, India.
Exposure to global pharmaceutical and clinical research quality systems.
Structured corporate quality framework with career development opportunities.
Collaborative and compliance-focused work culture.
This role provides foundational experience in:
Enterprise Quality Management Systems (eQMS)
GCP and GxP regulatory frameworks
Audit preparation and inspection readiness
Clinical compliance documentation processes
Future career pathways may 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 in the past five years. With over 29,000 employees worldwide, the organization collaborates across thousands of clinical trial sites to accelerate therapeutic innovation.
If you are looking to establish or advance your career in Pharmaceutical Quality Assurance, Clinical Compliance, or Audit Support, this hybrid opportunity in Gurugram offers structured exposure to global regulatory and quality systems.
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