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 [email protected]. Please feel free to reach out to HR Talent & Culture with any questions.

Clinical QA Specialist

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