PHARMAFull-time
Quality Assurance Associate (GCP Exp Required)
By Admin · Quality Assurance & Quality Control
HYDERABAD (IN)HYBRIDPOSTED: 10/2/2026
PHARMAFull-time
HIRING ORGANIZATIONSYNEOS HEALTHBiopharmaceutical / Healthcare Services
ROLE OVERVIEW
Quality Assurance Associate supporting sponsor audits, regulatory inspections, Quality Management System activities, documentation, and CAPA follow-up. The role requires 2-3 years of GCP and clinical research quality experience and is based in a hybrid model in Hyderabad or Gurugram.
ROLE DEFINITION & RESPONSIBILITIES
- •Act as the technical lead for hosting and supporting sponsor audits
- •Enter audit-related data into the enterprise Quality Management System
- •Assist in gathering documentation required for audits and inspections, including training records and organizational charts
- •Assist auditors in obtaining follow-up information during customer audits and regulatory inspections
- •Assist auditors with Corrective Action/Preventive Action (CAPA) follow-up
- •Maintain, file, and archive relevant Quality Assurance documentation
- •Perform other work-related duties as assigned
Reporting Hierarchy: Reports to the relevant Quality Assurance leadership or manager; Team structure and direct reporting line are not specified in the source posting
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree or equivalent with minimal experience in a healthcare or clinical research environment
- Good understanding of Good Clinical Practice (GCP)
- 2-3 years of experience in GCP, supporting client audits, QMS activities, and CAPA follow-up
- Computer literacy including Microsoft Office and basic SharePoint proficiency
- Ability to handle multiple tasks and meet timelines
- Strong organizational, presentation, interpersonal, and communication skills
PREFERRED QUALIFICATIONS
- •Experience in sponsor audits and regulatory inspections
- •Experience with enterprise Quality Management Systems
- •Experience preparing or maintaining clinical quality documentation
- •Familiarity with diverse global stakeholder environments
REQUIRED VERIFIED SKILLS
GCP
Good Clinical Practice
Quality Assurance
Quality Management System
QMS
CAPA
sponsor audits
regulatory inspections
clinical research
audit documentation
Microsoft Office
SharePoint
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Career development and progression; supportive line management; technical and therapeutic area training; peer recognition; total rewards program; inclusive work environment
The source posting does not disclose a salary range, bonus, or equity package. Compensation should therefore be confirmed directly through the employer during the recruitment process.
ORGANIZATION CONTEXT & CULTURE
Syneos Health is a leading fully integrated life sciences services organization that partners with innovators across the drug development and commercialization continuum. The company states that it has approximately 25,000 colleagues globally.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare Services
Culture: Collaborative, agile, inclusive, and customer-focused culture. Syneos Health emphasizes professional development, peer recognition, technical training, and its purpose of being Driven to Deliver.
EXPECTED CAREER ROADMAP
The role can provide progression within clinical quality and Quality Assurance functions toward senior QA, quality systems, audit/inspection management, and broader clinical quality leadership responsibilities, subject to individual performance and organizational opportunities.
APPLICATION ADVISORY
Highlight 2-3 years of GCP experience; clearly demonstrate sponsor audit and regulatory inspection support; describe hands-on QMS and CAPA follow-up experience; emphasize clinical research quality documentation skills; mention Microsoft Office and SharePoint proficiency; demonstrate ability to manage multiple deadlines and communicate with diverse stakeholders.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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