CQA Document Control Associate Job – at Ora, Apply Now!
Are you passionate about quality systems and clinical documentation? Join Ora, a global leader in ophthalmic clinical research, as a CQA Document Control Associate in Hyderabad. This role offers the opportunity to work with electronic document management systems, support quality compliance, and contribute to the future of ophthalmology research. If you’re detail-oriented, tech-savvy, and ready to make an impact in life sciences, this is your moment.
Position Title: CQA Document Control Associate
Department: Clinical Quality Assurance
Location: Hyderabad, Telangana, India
About The Company
Ora is a leading full-service ophthalmic drug and device development firm dedicated to shaping the future of ophthalmic clinical research. With over 45 years of experience, Ora’s expert teams have facilitated more than 85 new product approvals by guiding clients through all phases of clinical research. Our commitment to operational excellence, scientific rigor, kindness, and joy underpins everything we do. Join us in our mission to revolutionize ophthalmology worldwide.
The Role:
Our global Clinical Quality Assurance (CQA) Document Control Associate will support our Quality Management team in maintaining accuracy and efficiency in the Quality Document Control system. This role entails maintaining electronic training files, tracking compliance, and
ensuring adherence to guidelines and regulations.Key Responsibilities:
- Maintain clinical documentation databases and assist in QMS metrics tracking
- Support document revisions and change management
- Upload, assign, and monitor training assignments via EMS
- Review and process external document distribution requests
- Maintain and audit quality documentation and training records
- Provide assistance during audits and compliance checks
- Collaborate across departments to maintain training compliance
- Maintain confidentiality and adhere to GCP/GLP/GMP and regulatory requirements
- Demonstrate Ora’s values: Kindness, Joy, Scientific Rigor, and Operational Excellence
Qualifications
- Bachelor’s degree in Life Sciences or 1+ years of experience in a quality-related role
- Familiarity with GCP, GLP, or GMP guidelines is preferred
- Hands-on experience with document management/training software
- Proficient in Microsoft Office (Word, Excel, Outlook)
- Strong written and verbal communication skills
- Attention to detail, organizational, and time-management abilities
- Able to work well independently and in cross-functional teams
- Experience with EMS/LMS platforms is a plus
Keywords: Job posting, CQA Document Control Associate, Clinical Quality Assurance, Ora, ophthalmic research
