Transforming Lives by Unlocking Better Evidence | Decentralized clinical trials | Broadest endpoint technology
Quality Assurance Coordinator
Location
India
Posted
1 day ago
Salary
0
Seniority
Junior
Job Description
Quality Assurance Coordinator
Clario
• Coordinate and support pre- and post-audit and inspection activities under the guidance of QA leadership • Schedule audits and inspections, ensuring availability of key stakeholders and subject matter experts • Partner with audit/inspection hosts to organize required documentation and ensure readiness • Collaborate with cross-functional teams to maintain audit- and inspection-ready processes • Identify documentation gaps and report findings to appropriate stakeholders • Support preparation and coordination of preliminary audit response activities • Maintain and organize audit and inspection documentation within designated repositories • Assist in maintaining audit and inspection libraries and supporting related QA projects • Participate in audit or inspection activities, including potential travel to support on-site needs when required • Operate effectively across different time zones to support global processes
Job Requirements
- Associate or Bachelor’s degree and/or equivalent experience or certifications
- Minimum 1 year experience in a GxP-regulated or highly regulated environment
- Experience supporting complex scheduling activities in a fast-paced environment
- Exposure to audits or regulatory inspections preferred
- Knowledge of regulatory standards including ICH GCP, 21 CFR Part 11, 21 CFR 820.20, ISO 9001, ISO 13485, and ISO 27001 preferred
- Strong organizational, analytical, and communication skills
- Ability to manage multiple priorities and meet deadlines in a global environment
- Detail-oriented with strong written documentation skills
- Proficiency in MS Office suite and Microsoft Teams for collaboration and reporting
- Ability to work independently and as part of a cross-functional team
- Flexibility to work occasional non-standard hours aligned to global operations
- Strong English language proficiency (written and verbal).
Benefits
- Competitive pay and incentives
- Provident Fund and medical insurance
- Engaging employee programs and local events
- Modern office spaces and remote work flexibility
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