Job Title: Quality Assurance Associate
Location: Hyderabad, India (Hybrid Work Model)
Job ID: 25105205
Employment Type: Full-Time
Industry: Clinical Research | Pharmaceutical Quality Assurance | CRO | Regulatory Compliance
Syneos Health is recruiting a Quality Assurance Associate to support audit coordination, regulatory inspection readiness, and enterprise quality management system (eQMS) activities at its Hyderabad location. This hybrid role offers strong exposure to global clinical research operations and pharmaceutical compliance frameworks.
As a leading global biopharmaceutical solutions organization operating in over 110 countries, Syneos Health supports drug development, medical affairs, and commercialization strategies for major pharmaceutical and biotechnology companies.
The Quality Assurance Associate plays a key role in maintaining compliance standards by supporting the planning, tracking, and documentation of internal audits, customer audits, and regulatory inspections. The role ensures accurate data management within the enterprise Quality Management System and contributes to inspection readiness initiatives.
This position is ideal for professionals seeking career growth in:
Clinical Quality Assurance (CQA)
GCP and GxP Compliance
Regulatory Audit Support
Pharmaceutical Quality Systems
CRO Quality Operations
Assist in tracking scheduled and planned audits within the enterprise quality management system (eQMS).
Update audit calendars and compliance schedules as directed by management.
Gather required documentation for audits and regulatory inspections, including:
Training records
Organizational charts
SOP documentation
Compliance and quality records
Support auditors in obtaining follow-up documentation during customer audits and regulatory inspections.
Enter and maintain audit-related data accurately within the eQMS.
Maintain, organize, file, and archive Quality Assurance documentation in accordance with company SOPs and regulatory requirements.
Ensure document control, version accuracy, and proper record retention.
Assist in developing and maintaining QA tools, trackers, and documentation templates.
Support overall inspection readiness and compliance monitoring activities.
Perform other QA and compliance-related duties as assigned.
Collaborate with cross-functional teams in a global corporate environment.
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 support is preferred.
Recent graduates with relevant internships or academic exposure to QA or clinical operations may be considered.
Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Healthcare Management, or a related discipline.
Equivalent combination of education and relevant experience may be considered.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Basic familiarity with SharePoint or electronic document management systems preferred.
Strong organizational and multitasking abilities.
Ability to meet deadlines in a fast-paced, compliance-driven environment.
Effective written and verbal communication skills.
Cultural sensitivity and ability to work with diverse global stakeholders.
Strong attention to detail and documentation accuracy.
Ability to follow structured processes under detailed supervision.
Hybrid work model based in Hyderabad, India.
Exposure to global pharmaceutical quality systems and clinical compliance frameworks.
Structured corporate quality environment with defined career progression pathways.
Collaborative, inclusive, and performance-driven culture.
This role provides foundational experience in:
Enterprise Quality Management Systems (eQMS)
GCP and GxP regulatory standards
Audit preparation and inspection readiness
Clinical research compliance processes
Potential career progression includes:
Clinical Quality Assurance Specialist
QA Auditor
Regulatory Affairs Associate
Quality Systems Analyst
Syneos Health is a global biopharmaceutical solutions company that has contributed to 94% of novel FDA-approved drugs and 95% of EMA-authorized products over the past five years. With over 29,000 employees worldwide, the organization supports clinical research programs across thousands of sites globally.
If you are looking to establish your career in Pharmaceutical Quality Assurance, Clinical Compliance, or Audit Support, this hybrid opportunity in Hyderabad offers structured exposure to global regulatory standards within a leading CRO environment.
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