This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Quality Assurance Coordinator based in India.
This role offers the opportunity to support quality and regulatory compliance activities within a highly regulated clinical research and healthcare technology environment.
You will coordinate audit and inspection readiness activities, ensuring teams have the documentation, schedules, and information needed to respond effectively.
The position involves close collaboration with Quality Assurance, Regulatory Compliance, management, and global cross-functional stakeholders.
You will play an important role in maintaining accurate quality records and identifying gaps that could affect inspection readiness.
The role combines project coordination, documentation management, stakeholder communication, and continuous improvement.
You will work in a collaborative, deadline-driven environment where attention to detail and operational discipline are highly valued.
This is an excellent opportunity to develop your expertise in quality systems, regulatory compliance, and global audit and inspection processes.
Accountabilities:
- Coordinate pre-audit, audit, inspection, and post-inspection activities under the direction of Quality Assurance and Regulatory Compliance leadership.
- Schedule audits and regulatory inspections while managing associated logistics, timelines, documentation, and stakeholder communications.
- Partner with audit and inspection hosts to organize required documentation, supporting evidence, schedules, and subject matter expert availability.
- Work with management and cross-functional teams to ensure projects, processes, and documentation remain audit and inspection ready.
- Review documentation for completeness, accuracy, and consistency, identifying gaps, risks, or missing information that may affect readiness.
- Assist with collecting, tracking, organizing, and coordinating responses to preliminary audit findings and inspection observations.
- Maintain audit and inspection archives, libraries, and quality documentation within designated repositories and systems.
- Coordinate project documentation, schedules, data requests, action items, and stakeholder activities associated with quality and regulatory compliance programs.
- Support the maintenance of quality systems documentation and contribute to the accuracy and integrity of compliance records.
- Assist with special projects, process improvement initiatives, and other quality-related activities as required.
- Support global audits and inspections by coordinating with stakeholders across different regions and time zones.
- Promote a culture of quality, compliance, continuous improvement, and operational excellence across assigned activities.
Requirements:
- Associate’s or Bachelor’s degree, or an equivalent combination of education, certifications, and relevant professional experience.
- 1–3 years of experience working in a GxP-regulated environment or another highly regulated industry.
- Experience coordinating complex schedules, meetings, documentation, projects, or operational activities with multiple stakeholders.
- Exposure to audits, regulatory inspections, quality systems, or compliance programs is preferred.
- Familiarity with quality and regulatory frameworks such as ICH GCP, 21 CFR Part 11, 21 CFR 820, ISO 9001, ISO 13485, ISO 27001, or related standards is an advantage.
- Strong proficiency with Microsoft Office applications, particularly Outlook, Word, Excel, PowerPoint, and Microsoft Teams.
- Excellent organizational and project coordination skills, with the ability to manage multiple priorities, deadlines, and stakeholders simultaneously.
- Strong written and verbal English communication skills, with the ability to communicate clearly with global teams.
- Excellent attention to detail, analytical ability, and commitment to documentation accuracy.
- Experience with Quality Management Systems such as TrackWise or Veeva is an added advantage.
- Ability to work independently while collaborating effectively with geographically distributed teams.
- Willingness and ability to work primarily during US business hours, approximately 5:00 PM to 2:00 AM IST.
- Flexibility to periodically work non-standard hours to support global audits, inspections, and compliance activities.
- Professional, dependable, and quality-focused approach to working in deadline-driven environments.
Benefits:
- Competitive compensation and incentive opportunities.
- Provident fund and medical insurance.
- Remote work flexibility and access to modern office facilities.
- Employee engagement programs and local events.
- Opportunities for professional development, learning, and career growth within a global organization.
- Exposure to international quality, regulatory, audit, and inspection activities.
- Opportunity to collaborate with global teams and gain experience in highly regulated clinical research and healthcare technology environments.
- Meaningful work supporting quality and compliance activities that contribute to the advancement of clinical research and healthcare technologies.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
#LI-CL1
