Remote - India
Job Description
The Clinical QA Specialist performs QA activities in assigned areas per the Quality Management System (QMS).
Responsibilities & Accountabilities
- Conducts and/or participates in QA activities that include, but not limited to:
- Audit activities, including planning, conduct, response, and documentation
- Quality issues, complaints, nonconformities and Corrective and Preventive Actions (CAPA)
- Vendor/ supplier qualifications
- Quality management review
- QA and regulatory compliance reviews of documentation
- Periodic review of controlled documentation, and assessments of internal files
- Performs document control activities, including quality record maintenance.
- Performs activities related to personnel training and maintenance of training documentation.
- Involved in administration and overall maintenance of the company's eQMS
- Contributes to development, review, and revision of procedures in accordance with the QMS.
- Assist with regulatory submissions related to the proprietary medical device software.
- Participates in QA-related meetings: scheduling, agenda, minutes, and action item management.
- Provides QA and regulatory compliance guidance and feedback cross-departmentally.
- Reports quality aspects to departmental Lead or Officers as part of management review.
- Performs other departmental activities as needed and upon request.
Education & Experience
- Requires undergraduate degree and at least 3 years of experience in activities related to quality, or an acceptable combination of education and experience.
- Experience in medical device, pharmaceutical and/or biotech clinical research industry a must.
- Working knowledge of regulations, standards and guidelines related to quality in clinical trials.
- Experience in regulatory submission activities for medical devices preferred.
- Knowledge of eQMS a plus.
- Excellent written and oral communication, attention to detail, organizational and planning skills.
- Ability to perform and maintain quality work while prioritizing and managing multiple deadlines.
- Ability to work with different departmental designees on quality-related activities .
Work Location: Remote
Candidates can send their CV to [Confidential Information]. Please feel free to reach out to HR Talent & Culture with any questions.
