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Ora Clinical, a global leader in ophthalmic drug and device development, is hiring a CQA Document Control Associate to strengthen its Clinical Quality Assurance (CQA) team. With over 45 years of expertise and more than 85 new product approvals, Ora is expanding its Hyderabad office and seeking talented life sciences professionals to help maintain high-quality documentation and training compliance.
Key Responsibilities
As a CQA Document Control Associate, you will:
- Maintain clinical documentation databases and electronic management systems (EMS) with accuracy.
- Track and run reports on Quality Assurance (QA) metrics for senior management.
- Assist with revision, editing, and change management of Quality Management System (QMS) documents, including SOPs, policies, work instructions, and forms.
- Upload, assign, and track training within Ora’s EMS platform.
- Review, approve, and distribute QA documents externally using the approved sharing system.
- Support the management of EMS user accounts, access issues, and document uploads.
- Maintain organized records of all quality and operational documents.
- Adhere to Ora’s quality system, data integrity, and regulatory compliance requirements.
Required Qualifications
- Education: Bachelor’s degree in Life Sciences or 1+ year of experience in a quality-related field.
- Technical Skills: Experience with document management systems, Microsoft Word, Excel, and Outlook.
- Clinical Knowledge: Familiarity with clinical trials, GCP, GLP, GMP, and QA practices.
- Soft Skills: Excellent communication, teamwork, time management, attention to detail, and customer service orientation.
Benefits
- Work for a global ophthalmic clinical research leader.
- Opportunity for professional development and training in QA and EMS systems.
- Collaborative and inclusive work culture emphasizing kindness, joy, operational excellence, and scientific rigor.
- Flexible travel requirements (<10% domestic).
How to Apply
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