Quality Assurance Associate (*GCP* Exp Required)

Syneos Health, Inc.; Hyderabad; On-site; INR 600,000 - 900,000; Full time

Benefits offered by this job

None

Job summary

Syneos Health, Inc. is seeking a Quality Assurance Associate with GCP experience to lead sponsor audits and maintain QA documentation. You will support audit preparations, assist in CAPA follow-up, and manage data entry in the QA system.

The role requires capability to handle multiple tasks and strong communication across teams. The successful candidate will have 2-3 years of GCP-focused experience within a clinical research environment and a bachelor’s degree or equivalent.

Qualifications

• Bachelor's degree or equivalent in health care or clinical research.
• Strong understanding of Good Clinical Practice (GCP).
• Experience supporting audits, CAPA, and QA documentation.

Responsibilities

• Act as technical lead for hosting sponsor audits.
• Enter audit data into the enterprise quality management system.
• Assist in gathering documentation for audits and inspections.
• Support CAPA follow-up and audit inquiries.
• Maintain QA documentation and archives.

Skills

GCP knowledge

Audit support

QMS activities

MS Office

Communication

Education

Bachelor's degree or equivalent

Tools

SharePoint

MS Office

Job description

Quality Assurance Associate (\\*GCP\\* Exp Required)Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring together talented experts across a broad spectrum of business critical corporate functions. Every role plays an essential part in enabling our customers to achieve their goals. Our teams are agile, collaborative, and committed to delivering—for each other, for our customers, and ultimately for the people who rely on the services we support. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.**Job Responsibilities**General Profile* Act as the technical lead for hosting/supporting sponsor audits.* Enters audit-related data into the enterprise quality management system.* Assists in gathering documentation required by auditors for audits and inspections (e.g. training records, organizational charts).* Assists auditors in obtaining follow-up information during customer audits and regulatory inspections.* Assists auditors in Corrective Action/Preventive Action (CAPA) Follow-up.* Maintains, files, and archives relevant Quality Assurance (QA) documentation.Supervision* Normally receives detailed instructions on day -to-day work and detailed instructions on new assignments.Other tasks* Performs other work-related duties as assigned.QUALIFICATION REQUIREMENTS (please indicate if ‘preferred’)* Requires a Bachelor’s degree or equivalent with minimal experience in a health care or clinical research environment* Good understanding of Good Clinical Practice (GCP).* 2-3 years of experience in GCP, supporting client audits, Quality Management System (QMS) activities, and CAPA follow-up activities.* Computer literacy commensurate with job requirements (Microsoft Office suite; basic SharePoint proficiency).* Able to handle multiple tasks to meet timelines in a dynamic environment.* Strong organizational, presentation and interpersonal skills.* Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds.* Well-developed communication skills and the ability to write necessary documentation (e.g. tools).